Drugs Details

Drugs Info of Ontak
Drugs Details
  • Drugs Type  : FDA
  • Date : 26th Feb 2015 02:53 am
  • Brand Name : Ontak
  • Generic Name : denileukin diftitox (Pronunciation: de ni LOO kin DIF ti tox)
Descriptions

Ontak (denileukin diftitox), is a recombinant DNA-derived cytotoxic protein composed of the amino acid sequences for diphtheria toxin fragments A and B (Met1-Thr387)-His and the sequences for human interleukin-2 (IL-2; Ala1-Thr133). It is produced in an E. coli expression system and has a molecular weight of 58 kD. Neomycin is used in the fermentation process but is undetectable in the final product. Ontak (denileukin diftitox) is supplied in single use vials as a sterile, frozen solution intended for intravenous (IV) administration. Each 2 mL vial of Ontak contains 300 mcg of recombinant denileukin diftitox in a sterile solution of citric acid (20 mM), EDTA (0.05 mM) and polysorbate 20 ( < 1%) in Water for Injection, USP. The solution has a pH range of 6.9 to 7.2.

What are the possible side effects of denileukin diftitox (Ontak)?

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • blurred vision, changes in color vision;
  • swelling in your...

Read All Potential Side Effects and See Pictures of Ontak »

What are the precautions when taking denileukin diftitox (Ontak)?

Before receiving denileukin diftitox, tell your doctor or pharmacist if you are allergic to it; or to diphtheria toxin/vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease, any current infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have...

Read All Potential Precautions of Ontak »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Ontak® (denileukin diftitox) is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor [see WARNINGS AND PRECAUTIONS].

Dosage Administration

Dosing Schedule and Administration

  • Premedicate with an antihistamine and acetaminophen prior to each Ontak (denileukin diftitox) infusion.
  • Administer at 9 or 18 mcg/kg/day by intravenous infusion over 30-60 minutes for 5 consecutive days every 21 days for 8 cycles.
  • Do not administer as a bolus injection.
  • Withhold administration of Ontak (denileukin diftitox) if serum albumin levels are less than 3.0 g/dL.
  • Discontinue for adverse infusion reactions.

Preparation and Administration

  • Thaw vials in the refrigerator at 2 to 8°C (36 to 46°F) for not more than 24 hours or at room temperature for 1 to 2 hours.
  • Bring Ontak (denileukin diftitox) to room temperature, before preparing the dose.
  • Mix the solution in the vial by gentle swirling; do not shake.
  • Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if the solution is clear, colorless and without visible particulate matter. After thawing, a haze may be visible which should clear when the solution is at room temperature.
  • Do not refreeze Ontak (denileukin diftitox) after thawing.
  • Prepare and hold diluted Ontak (denileukin diftitox) in plastic syringes or soft plastic IV bags. Do not use glass containers.
  • Maintain concentration of Ontak (denileukin diftitox) at 15 mcg/mL or higher
  • during all steps in the preparation of the solution for IV infusion.
  • Withdraw the calculated dose from the vial(s) and inject it into an empty IV infusion bag. Do not add more than 9 mL of sterile saline without preservative to the IV bag for each 1 mL of Ontak (denileukin diftitox) .
  • Do not mix Ontak (denileukin diftitox) with other drugs.
  • Do not administer Ontak (denileukin diftitox) through an in-line filter.
  • Administer prepared solutions of Ontak (denileukin diftitox) within 6 hours, using a syringe pump or IV infusion bag.
  • Discard unused portions of Ontak (denileukin diftitox) immediately.

How Supplied

Dosage Forms And Strengths

Single-use vial containing 150 mcg/mL (300 mcg in 2 mL).

Storage And Handling

Ontak (denileukin diftitox) is supplied as 150 mcg/ml, sterile, frozen solution (300 mcg in 2 mL) in a sterile single-use vial.NDC 62856-603-01, 6 vials in a package.

Store frozen at or below -10° C (14° F).

Manufactured by: Eisai Medical Research Inc. Ridgefield Park, NJ 07660. Manufactured at: Hollister-Stier Labs LLC Spokane, WA 99207. Distributed by: Eisai Inc., Woodcliff Lake, NJ 07677. FDA revision date: 10/16/2008


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Infusion Reactions [seeWARNINGS AND PRECAUTIONS ]
  • Capillary Leak Syndrome [see WARNINGS AND PRECAUTIONS]
  • Visual Loss [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Safety data are available for 3 clinical studies in which 234 patients received Ontak (denileukin diftitox) at 9 mcg/kg (n=80) or 18 mcg/kg (n=154) at the recommended schedule. Of these studies, 1 was placebo-controlled and dose-ranging (Study 1, 100 Ontak (denileukin diftitox) -treated patients), one was a dose-comparison of 9 and 18 mcg/kg (Study 2, n=71), and the third was a single-arm study using 18 mcg/kg (n=63); all studies were limited to adult patients with CTCL. The median age of patients across the clinical studies was 60 years (range 23-91 years) and 36% (n=85) were 65 years of age or older; 55% were men and 85% were Caucasian.

Across all 3 studies, the most common adverse reactions in Ontak (denileukin diftitox) -treated patients ( ≥ 20%) were pyrexia, nausea, fatigue, rigors, vomiting, diarrhea, headache, peripheral edema, cough, dyspnea and pruritus. The most common serious adverse reactions were capillary leak syndrome (11.1%), infusion reactions (8.1%), and visual changes including loss of visual acuity (4%). Ontak (denileukin diftitox) was discontinued in 28.2% (66/234) of patients due to adverse reactions.

The data described in Table 1 reflect exposure to Ontak (denileukin diftitox) in 100 patients administered as a single agent at the recommended dosing schedule in the randomized placebo-controlled trial (Study 1). The median number of Ontak (denileukin diftitox) cycles was 7 (range 1-10) for the 9 mcg/kg cohort and 6 (range 1-11) for the 18 mcg/kg cohort. The median age of patients was 59 years (range 23-84 years) and 34% (n=34) were 65 years of age or older; 55% were men and 86% were Caucasian.

Table 1: Incidence of Adverse Reactions Occurring in ≥ 10% of Ontak (denileukin diftitox) -treated patients (18 mcg/kg group) and at a higher rate than Placebo in Study 1

MedDRA
version 6.1
Preferred Term
Placebo
N=44
n (%)
Ontak (denileukin diftitox)
9 mcg/kg
N=45
n (%)
Ontak (denileukin diftitox)
18 mcg/kg
N=55
n (%)
Pyrexia 7 (15.9) 22 (48.9) 35 (63.6)
Nausea 10 (22.7) 21 (46.7) 33 (60.0)
Rigors 9 (20.5) 19 (42.2) 26 (47.3)
Fatigue 14 (31.8) 21 (46.7) 24 (43.6)
Vomiting 3 (6.8) 6 (13.3) 19 (34.5)
Headache 8 (18.2) 13 (28.9) 14 (25.5)
Edema peripheral 10 (22.7) 9 (20.0) 14 (25.5)
Diarrhea 4 (9.1) 10 (22.2) 12 (21.8)
Anorexia 2 (4.5) 4 (8.9) 11 (20.0)
Rash 2 (4.5) 11 (24.4) 11 (20.0)
Myalgia 2 (4.5) 8 (17.8) 11 (20.0)
Cough 3 (6.8) 9 (20.0) 10 (18.2)
Pruritus 4 (9.1) 7 (15.6) 10 (18.2)
Back pain 1 (2.3) 7 (15.6) 10 (18.2)
Asthenia 2 (4.5) 8 (17.8) 10 (18.2)
Hypotension 1 (2.3) 3 (6.7) 9 (16.4)
Upper respiratory tract infection 5 (11.4) 6 (13.3) 7 (12.7)
Dizziness 5 (11.4) 5 (11.1) 7 (12.7)
Arthralgia 5 (11.4) 7 (15.6) 7 (12.7)
Pain 3 (6.8) 5 (11.1) 7 (12.7)
Chest pain 1 (2.3) 2 (4.4) 7 (12.7)
Dysgeusia 1 (2.3) 0 (0) 6 (10.9)
Dyspnea 2 (4.5) 6 (13.3) 6 (10.9)

Hepatobiliary Disorders: Increase in serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) from baseline occurred in 84% of subjects treated with Ontak (denileukin diftitox) (197/234). In the majority of subjects, these enzyme elevations occurred during either the first or the second cycle; enzyme elevation resolved without medical intervention and did not require discontinuation of Ontak (denileukin diftitox) .

Immunogenicity

An immune response to denileukin diftitox was assessed using 2 enzyme-linked immunoassays (ELISA). The first assay measured reactivity directed against intact denileukin diftitox calibrated against anti-diphtheria toxin, and the second assay measured reactivity against the IL-2 portion of the protein. An additional in vitro cell-based assay that measured the ability of antibodies in serum to protect a human IL-2R-expressing cell line from toxicity by denileukin diftitox, was used to detect the presence of neutralizing antibodies which inhibited functional activity. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to the intact fusion protein denileukin diftitox. These results are highly dependent on the sensitivity and the specificity of the assays. Additionally, the observed incidence of the antibody positivity may be influenced by several factors, including sample handling, concomitant medication, and underlying disease. For these reasons, the comparison of the incidence of antibodies to denileukin diftitox with the incidence of antibodies to other products may be misleading.

In Study 1 [see Clinical Studies], of 95 patients treated with denileukin diftitox, 66% tested positive for antibodies at baseline probably due to a prior exposure to diphtheria toxin or its vaccine. After 1, 2, and 3 courses of treatment, 94%, 99%, and 100% of patients tested positive, respectively. Mean titers of anti-denileukin diftitox antibodies were similarly increased in the 9 and 18 mcg/kg/day dose groups after 2 courses of treatment. Meanwhile, pharmacokinetic parameters decreased substantially (Cmax~57%, AUC~80%), and clearance increased 2- to 8- fold.

In Study 2 [see Clinical Studies], 131 patients were assessed for binding antibodies. Of these, 51 patients (39%) had antibodies at baseline. Seventy-six percent of patients tested positive after 1 course of treatment and 97% after 3 courses of treatment. Neutralizing antibodies were assessed in 60 patients; 45%, 73%, and 97% had evidence of inhibited functional activity in the cellular assay at baseline and after 1 and 3 courses of treatment, respectively.

Read the Ontak (denileukin diftitox) Side Effects Center for a complete guide to possible side effects

Interactions

No formal drug-drug interaction studies have been conducted with Ontak (denileukin diftitox) .


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Infusion Reactions

Infusion reactions, defined as symptoms occurring within 24 hours of infusion and resolving within 48 hours of the last infusion in that course, were reported in 70.5% (165/234) of Ontak (denileukin diftitox) -treated patients across 3 clinical studies utilizing the approved doses and schedule. Serious infusion reactions were reported in 8.1% (19/234) of Ontak (denileukin diftitox) -treated patients. There have been post-marketing reports of infusion reactions resulting in death. For patients completing at least 4 courses of Ontak treatment in Study 1[see Clinical Studies], the incidence of infusion reactions was lower in the 3rd and 4th cycles as compared to the 1st and 2nd cycles of Ontak (denileukin diftitox) .

Resuscitative equipment should be available during Ontak (denileukin diftitox) administration. Immediately stop and permanently discontinue Ontak (denileukin diftitox) for serious infusion reactions.

Capillary Leak Syndrome

Capillary leak syndrome was defined as the occurrence of at least 2 of the following 3 symptoms (hypotension, edema, serum albumin < 3.0 g/dL) at any time during Ontak (denileukin diftitox) therapy. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome. As defined, capillary leak syndrome was reported in 32.5% (76/234) of Ontak (denileukin diftitox) -treated patients. Among these 76 patients with capillary leak syndrome, one-third required hospitalization or medical intervention to prevent hospitalization. There have been post-marketing reports of capillary leak syndrome resulting in death.

The onset of symptoms in patients with capillary leak syndrome may be delayed, occurring up to 2 weeks following infusion. Symptoms may persist or worsen after the cessation of Ontak (denileukin diftitox) .

Regularly assess patients for weight gain, new onset or worsening edema, hypotension (including orthostatic changes) and monitor serum albumin levels prior to the initiation of each course of therapy and more often as clinically indicated. Withhold Ontak (denileukin diftitox) for serum albumin levels of less than 3.0 g/dL [see WARNINGS AND PRECAUTIONS].

Visual Loss

Loss of visual acuity, usually with loss of color vision, with or without retinal pigment mottling has been reported following administration of Ontak (denileukin diftitox) . Recovery was reported in some of the affected patients; however, most patients reported persistent visual impairment.

CD25 Tumor Expression and Evaluation

Confirm that the patient's malignant cells express CD25 prior to administration of Ontak (denileukin diftitox) . A testing service for the assay of CD25 expression in tumor biopsy samples is available. For information on this service call 877-873-4724.

Laboratory Monitoring/Hypoalbuminemia

Monitor serum albumin levels prior to the initiation of each treatment course. Withhold administration of Ontak (denileukin diftitox) if serum albumin levels are less than 3.0 g/dL [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no studies to assess the carcinogenic potential of denileukin diftitox. Denileukin diftitox showed no evidence of mutagenicity in the Ames test and the chromosomal aberration assay. There have been no studies to assess the effect of denileukin diftitox on fertility.

Use In Specific Populations

Pregnancy

It is not known whether Ontak (denileukin diftitox) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Animal reproduction studies have not been conducted with Ontak (denileukin diftitox) . Ontak (denileukin diftitox) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Ontak (denileukin diftitox) is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Ontak (denileukin diftitox) , a decision should be made whether to discontinue nursing or to discontinue Ontak (denileukin diftitox) , taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Ontak (denileukin diftitox) did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Doses of approximately twice the recommended dose (31 mcg/kg/day) resulted in moderate-to-severe nausea, vomiting, fever, chills and/or persistent asthenia.

ContrainDications

None.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

Denileukin diftitox is a fusion protein designed to direct the cytocidal action of diphtheria toxin to cells which express the IL-2 receptor. Ex vivo studies report that after binding to the IL-2 receptor on the cell surface, denileukin diftitox is internalized by receptor-mediated endocytosis. The fusion protein is subsequently cleaved, releasing diphtheria toxin enzymatic and translocation domains from the IL-2 fragment, resulting in the inhibition of protein synthesis and ultimately, cell death.

Pharmacokinetics

Pharmacokinetic parameters associated with denileukin diftitox were determined over a range of doses (3 to 31 mcg/kg/day) in patients with lymphoma. Denileukin diftitox was administered as an IV infusion following the schedule used in the clinical trials. Following the first dose, denileukin diftitox displayed 2-compartment behavior with a distribution phase (half-life approximately 2 to 5 minutes) and a terminal phase (half-life approximately 70 to 80 minutes). Systemic exposure was variable but proportional to dose. Mean clearance was approximately 0.6 to 2.0 mL/min/kg and the mean volume of distribution was similar to that of circulating blood (0.06 to 0.09 L/kg). The mean clearance increased approximately 2- to 8-fold from course 1 to course 3 corresponding to a decrease in exposure of approximately 75%. No accumulation was evident between the first and fifth doses. Gender and age have no effect on pharmacokinetics of denileukin diftitox.

Clinical Studies

Study 1: Placebo Controlled Study in CTCL (Stage Ia to III) Patients

The safety and efficacy of Ontak (denileukin diftitox) were evaluated in a randomized, double-blind, placebo-controlled, 3-arm trial in patients with Stage Ia to III CD25(+) CTCL. Eligible patients were required to have expression of CD25 on ≥ 20% of biopsied malignant cells by immunohistochemistry [seeWARNINGS AND PRECAUTIONS]. Patients were randomized to receive 0, 9 or 18 mcg/kg/day Ontak (denileukin diftitox) via intravenous infusion days 1-5 of each 21-day cycle, for up to 8 cycles. Randomization was stratified by disease stage ( ≤ IIa vs. ≥ IIb). The main efficacy outcome was objective response rate (ORR), using a Weighted Skin Severity Index, in conjunction with assessment of lymph node involvement and percentage of abnormal blood lymphocytes. A total of 144 patients were randomized: 44 patients to placebo, 45 patients to 9 mcg/kg/day Ontak (denileukin diftitox) and 55 patients to 18 mcg/kg/day Ontak (denileukin diftitox) . Randomization for the study was carried out at 1:1:1 for the first 73 patients, 4:1:4 for the next 31 patients, and 1:4:4 for the remaining 40 patients. The median age of patients was 59 years (range 23 to 84 years); 34% were ≥ 65 years. Fifty-five percent were men and 86% were Caucasian. Sixty-seven percent had early stage disease ( ≤ IIa). Patients had received a median of 2 anti-CTCL therapies (range 0 to 6) prior to study entry. Results for objective response rate (ORR) and progression-free survival (PFS) are shown in the table below.

Table 2: Efficacy Results in Study 1

Efficacy Endpoint Ontak (denileukin diftitox)
18 mcg/kg/day
(N=55)
Ontak (denileukin diftitox)
9 mcg/kg/day
(N=45)
Placebo
(N=44)
ORR %a 46% 37% 15%
  p-valueb p=0.002 p=0.03 --
Median Response Duration 220 days 277 days 81 days
PFSc      
  Hazard ratio 0.27 0.42  
  (95% CI) (0.14, 0.54) (0.20, 0.86) --
  p-value p=0.0002 p=0.02  
a. Adjusted for disease stage and changes in randomization ratios
b. Logistic regression model adjusting for disease stage and changes in randomization ratios over the course of the study; comparisons relative to placebo.
c. Cox regression analysis stratified by randomization ratio and adjusted for disease stage; comparisons relative to placebo.
Study 2: Dose Evaluation Study in CTCL (Stage IIb to IVa) Patients

A randomized, double-blind study was conducted to evaluate doses of 9 or 18 mcg/kg/day in 71 patients with recurrent or persistent, Stage Ib to IVa CTCL. Entry to this study required demonstration of CD25 expression on at least 20% of the cells in any relevant tumor tissue sample (skin biopsy) or circulating cells. Tumor biopsies were not evaluated for expression of other IL-2 receptor subunit components (CD122/CD132). Ontak (denileukin diftitox) was administered as an IV infusion daily for 5 days every 3 weeks. Patients received a median of 6 courses of Ontak (denileukin diftitox) therapy (range 1 to 11). The study population had received a median of 5 prior therapies (range 1 to 12) with 63% of patients entering the trial with Stage IIb or more advanced stage disease. The median age of patients was 64 years (range 26 to 91 years); 49% were ≥ 65 years. Fifty-two percent were men and 75% were Caucasian.

Overall, 30% (95% CI: 18-41%) of patients treated with Ontak (denileukin diftitox) experienced an objective tumor response (50% reduction in tumor burden which was sustained for ≥ 6 weeks; Table 3). Seven patients (10%) achieved a complete response and 14 patients (20%) achieved a partial response. The overall median duration of response, measured from first day of response, was 4 months with a median duration for complete response of 9 months and for partial response of 4 months.

Table 3: Efficacy Results in Study 2

Clinical Response 9 mcg/kg/day 18 mcg/kg/day
Complete Response 9% (3/35) 11% (4/36)
  95% Confidence Interval (2%, 23%) (3%, 26%)
Partial Response 14% (5/35) 25% (9/36)
  95% Confidence Interval (9%, 30%) (12%, 42%)
Overall Response 23% (8/35) 36 (13/36)
  95% Confidence Interval (10%, 40%) (21%, 54%)


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Advise patients to report:

  • Fever, chills, breathing problems, chest pain, tachycardia, and urticaria following infusion.
  • Rapid weight gain, edema, and orthostatic hypotension following infusion. Instruct patients to weigh themselves daily.
  • Visual loss, including loss of color vision.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DENILEUKIN DIFTITOX - INJECTION

 

(den-ih-LEW-kin DIFF-teh-tox)

 

COMMON BRAND NAME(S): Ontak

 

WARNING: Unlikely but very serious (possibly fatal) side effects may occur during treatment with denileukin diftitox. Tell your doctor immediately if you have any unusual symptoms during the infusion (see Side Effects section). Also tell your doctor immediately if you experience any of the following symptoms: dizziness, lightheadedness, fainting, sudden weight gain, swelling ankles/feet, or vision changes (e.g., loss of vision/color vision).

 

USES: Denileukin diftitox is used to treat a certain type of cancer (cutaneous T-cell lymphoma, also known as CTCL) in patients whose cancer keeps returning or in patients who have not responded to other cancer chemotherapy treatment. It works by killing certain blood/cancer cells from your immune system (e.g., B cells, T cells).

 

HOW TO USE: This medication is given by injection into a vein by a health care professional.

Dosage is based on your weight, medical condition, and response to treatment. This medication is usually given over at least 15 minutes for 5 days in a row. This treatment cycle is usually repeated every 21 days or as directed by your doctor.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Dizziness, back pain, mild rash/itching, flushing, fever, chills, muscle/joint pain, nausea, vomiting, or diarrhea may occur during or after the infusion. Tell your doctor or pharmacist immediately if any of these effects occur, persist, or worsen. Your doctor may stop/slow down the infusion, and/or prescribe additional medications to help control these symptoms. Headache, loss of appetite, sweating, or trouble sleeping may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these serious side effects occur: extreme thirst, very dry mouth, decreased urination, weakness, muscle cramps, chest pain/tightness, shortness of breath, fast/slow/irregular heartbeat, trouble swallowing, confusion, pain/redness/swelling of arms/legs/injection site, numbness/tingling of arms/legs.

This medication may cause very serious blood disorders (low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Ontak (denileukin diftitox) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before receiving denileukin diftitox, tell your doctor or pharmacist if you are allergic to it; or to diphtheria toxin/vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease, any current infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Laboratory and/or medical tests (e.g., weight, blood pressure, albumin levels, complete blood count, liver/kidney function tests, checking for arm/leg swelling) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor immediately to establish a new dosing schedule.

 

STORAGE: Not applicable. This medication is given in a hospital and will not be stored at home.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

 

Patient Detailed Side Effect

Brand Names: Ontak

Generic Name: denileukin diftitox (Pronunciation: de ni LOO kin DIF ti tox)

  • What is denileukin diftitox (Ontak)?
  • What are the possible side effects of denileukin diftitox (Ontak)?
  • What is the most important information I should know about denileukin diftitox (Ontak)?
  • What should I discuss with my health care provider before using denileukin diftitox (Ontak)?
  • How should I use denileukin diftitox (Ontak)?
  • What happens if I miss a dose (Ontak)?
  • What happens if I overdose (Ontak)?
  • What should I avoid while receiving denileukin diftitox (Ontak)?
  • What other drugs will affect denileukin diftitox (Ontak)?
  • Where can I get more information?

What is denileukin diftitox (Ontak)?

Denileukin diftitox is a designed protein containing toxins that attach themselves to certain types of malignant cells in the body. Denileukin diftitox works by destroying these malignant cells to slow the progression of cancer.

Denileukin diftitox is used to treat leukemia and lymphomas, including cutaneous (of the skin) T-cell lymphoma.

Denileukin diftitox may also be used for purposes not listed in this medication guide.

What are the possible side effects of denileukin diftitox (Ontak)?

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • blurred vision, changes in color vision;
  • swelling in your hands, ankles, or feet;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, cough, flu symptoms;
  • fast heart rate;
  • feeling light-headed, fainting;
  • back pain, trouble breathing, chest pain or tightness;
  • trouble swallowing, tight feeling in your throat; or
  • warmth or redness in your face, neck, or chest.

Less serious side effects may include:

  • headache, dizziness, or nervousness;
  • numbness or tingling;
  • runny or stuffy nose;
  • skin itching or rash;
  • weight gain or loss;
  • mild diarrhea or constipation; or
  • nausea, vomiting, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Ontak (denileukin diftitox) Side Effects Center for a complete guide to possible side effects

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What is the most important information I should know about denileukin diftitox (Ontak)?

You should not use denileukin diftitox if you have ever had an allergic reaction to a diphtheria vaccine or to medicines containing interleukin-2 (IL-2).

Denileukin diftitox is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. This medication must be given slowly, and the IV infusion can take at least 15 minutes to complete.

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Some patients receiving denileukin diftitox have had permanent changes in their vision or ability to see colors. Talk with your doctor about your individual risk. Tell your doctor if you have any vision changes during your treatment.

Side Effects Centers
  • Ontak

Patient Detailed How Take

What should I discuss with my health care provider before using denileukin diftitox (Ontak)?

You should not use denileukin diftitox if you have ever had an allergic reaction to a diphtheria vaccine or to medicines containing interleukin-2 (IL-2).

If you have heart disease, you may need a dose adjustment or special tests.

FDA pregnancy category C. It is not known whether denileukin diftitox will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether denileukin diftitox passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some patients receiving denileukin diftitox have had permanent changes in their vision or ability to see colors. Talk with your doctor about your individual risk. Tell your doctor if you have any vision changes during your treatment.

How should I use denileukin diftitox (Ontak)?

Denileukin diftitox is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. This medication must be given slowly, and the IV infusion can take at least 15 minutes to complete. During this time you will be observed for side effects.

Denileukin diftitox is usually given each day for 5 days, followed by 3 weeks off the medication.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis before and during your treatment. Visit your doctor regularly.

Side Effects Centers
  • Ontak

Patient Detailed Avoid Taking

What happens if I miss a dose (Ontak)?

Call your doctor for instructions if you miss an appointment for your denileukin diftitox injection.

What happens if I overdose (Ontak)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause severe nausea or vomiting, fever, chills, and extreme weakness.

What should I avoid while receiving denileukin diftitox (Ontak)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using denileukin diftitox.

What other drugs will affect denileukin diftitox (Ontak)?

There may be other drugs that can interact with denileukin diftitox. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about denileukin diftitox.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 3.04. Revision date: 12/15/2010.

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