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Denileukin diftitox Side Effects

Not all side effects for denileukin diftitox may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to denileukin diftitox: intravenous injectable, intravenous solution

In addition to its needed effects, some unwanted effects may be caused by denileukin diftitox. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking denileukin diftitox, check with your doctor or nurse immediately:

More common
  • Back pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • body aches or pain
  • chest pain
  • confusion
  • cough
  • difficulty with breathing
  • difficulty with moving
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • ear congestion
  • fast or irregular heartbeat
  • feeling unusually cold
  • fever or chills
  • headache
  • loss of appetite
  • loss of strength or energy
  • loss of voice
  • muscle aching or cramping
  • muscle pains or stiffness
  • nasal congestion
  • nausea
  • pain in the joints and muscles
  • rapid weight gain
  • rash
  • runny nose
  • shivering
  • shortness of breath
  • sneezing
  • sore throat
  • sweating
  • swollen joints
  • tightness in the chest
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
  • warmth and flushing of the skin
  • wheezing
Less common
  • Abdominal pain, severe
  • black, tarry stools
  • blood in the urine or stools
  • cloudy urine
  • cough or hoarseness accompanied by fever or chills
  • headache, severe
  • loss of coordination
  • lower back or side pain accompanied by fever or chills
  • pain in the groin or leg
  • painful or difficult urination accompanied by fever or chills
  • pinpoint red spots on the skin
  • slurring of speech
  • sudden vision changes
  • swelling or pain at the injection site
  • unusual bleeding or bruising
  • weakness of the arm and leg
Rare
  • Dry, puffy skin
  • increased heart rate
  • weight gain

Some of the side effects that can occur with denileukin diftitox may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Change in taste
  • diarrhea
  • itching
  • loss of taste
Less common
  • Constipation
  • indigestion
  • numbness or tingling of the fingers, toes, or face
  • runny nose
  • trouble with sleeping

For Healthcare Professionals

Applies to denileukin diftitox: intravenous solution

Other

Very common (10% or more): Infusion reactions (up to 70.5%), pyrexia (up to 63.6%), rigors (up to 47.3%), fatigue (up to 46.7%), peripheral edema (up to 25.5%), asthenia (up to 18.2%), pain (up to 12.7%), chest pain (up to 12.7%)[Ref]

Cardiovascular

Very common (10% or more): Capillary leak syndrome (up to 32.5%), hypotension (up to 16.4%)[Ref]

Ocular

Common (1% to 10%): Visual changes (e.g., visual acuity loss)[Ref]

Dermatologic

Very common (10% or more): Rash (up to 24.4%), pruritus (up to 18.2%)[Ref]

Endocrine

Postmarketing reports: Thyroid conditions (hyperthyroidism, thyroiditis, thyrotoxicosis, and hypothyroidism)

Gastrointestinal

Very common (10% or more): Nausea (up to 60%), vomiting (up to 34.5%), diarrhea (up to 22.2%)[Ref]

Hepatic

Very common (10% or more): Increased ALT or increased AST (up to 84%)[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 20%)[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 20%), back pain (up to 18.2%), arthralgia (up to 15.6%)[Ref]

Nervous system

Very common (10% or more): Headache (up to 28.9%), dizziness (up to 12.7%), dysgeusia (up to 10.9%)[Ref]

Respiratory

Very common (10% or more): Cough (up to 20%), upper respiratory tract infection (up to 13.3%), dyspnea (up to 13.3%)[Ref]

References

1. "Product Information. Ontak (denileukin diftitox)." Ligand Pharmaceuticals, San Diego, CA.

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