Desferal
Generic: DEFEROXAMINE MESYLATE
Basic Information
Manufacturer
Novartis Pharmaceuticals Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
a7174843-5965-49fc-b842-f7eff7b48bbc
Indications & Usage
1 INDICATIONS AND USAGE DESFERAL is an iron-chelating agent indicated: As an adjunct to standard measures for the treatment of acute iron intoxication.
( 1.1 ) For the treatment of transfusional iron overload in patients with chronic anemia.
( 1.2 ) Limitations of Use ( 1.3 ) Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).
1.1 Acute Iron Intoxication DESFERAL is indicated as an adjunct to standard measures for the treatment of acute iron intoxication.
1.2 Chronic Iron Overload DESFERAL is indicated for the treatment of transfusional iron overload in patients with chronic anemia.
1.3 Limitations of Use Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).
( 1.1 ) For the treatment of transfusional iron overload in patients with chronic anemia.
( 1.2 ) Limitations of Use ( 1.3 ) Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).
1.1 Acute Iron Intoxication DESFERAL is indicated as an adjunct to standard measures for the treatment of acute iron intoxication.
1.2 Chronic Iron Overload DESFERAL is indicated for the treatment of transfusional iron overload in patients with chronic anemia.
1.3 Limitations of Use Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Auditory and Ocular Toxicity [see Warnings and Precautions (5.2)] Renal Toxicity [see Warnings and Precautions (5.3)] Respiratory Toxicity [see Warnings and Precautions (5.4)] Growth Suppression [see Warnings and Precautions (5.5)] Serious Infections [see Warnings and Precautions (5.6)] Cardiac Dysfunction with Concomitant Use of Vitamin C [see Warnings and Precautions (5.7)] Risks of Desferal Treatment in Patients with Aluminum Overload [see Warnings and Precautions (5.8)] Effects on Ability to Drive and Use Machines [see Warnings and Precautions (5.9)] Most common adverse reactions are injection reactions (local and systemic), hypersensitivity reactions, infections with Yersinia and Mucormycosis, cardiovascular, gastrointestinal, hematologic, hepatic, musculoskeletal, urogenital, nervous, respiratory, ocular and hearing.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience The following adverse reactions associated with the use of Desferal were identified in clinical studies or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
At the Injection Site: Localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, local edema.
Injection site reactions may be associated with systemic allergic reactions (see Body as a Whole, below) .
Hypersensitivity Reactions and Systemic Allergic Reactions: Generalized rash, urticaria, anaphylactic reaction with or without shock, angioedema Body as a Whole: Local injection site reactions may be accompanied by systemic reactions like arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain, or asthma Infections: Yersinia, mucormycosis Cardiovascular: Tachycardia, hypotension, shock Digestive: Abdominal discomfort, diarrhea, nausea, vomiting Hematologic: Blood dyscrasia (thrombocytopenia, leucopenia) Hepatic: Increased transaminases, hepatic dysfunction Musculoskeletal: Muscle spasms.
Growth retardation and bone changes (e.g., metaphyseal dysplasia) Nervous System: Neurological disturbances, including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias, seizures; exacerbation or precipitation of aluminum-related dialysis encephalopathy Special Senses: High-frequency sensorineural hearing loss, tinnitus visual disturbances including acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts Respiratory: Acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates) Skin: Generalized rash Urogenital: Dysuria, acute renal failure, increased serum creatinine, and renal tubular disorders
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience The following adverse reactions associated with the use of Desferal were identified in clinical studies or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
At the Injection Site: Localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, local edema.
Injection site reactions may be associated with systemic allergic reactions (see Body as a Whole, below) .
Hypersensitivity Reactions and Systemic Allergic Reactions: Generalized rash, urticaria, anaphylactic reaction with or without shock, angioedema Body as a Whole: Local injection site reactions may be accompanied by systemic reactions like arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain, or asthma Infections: Yersinia, mucormycosis Cardiovascular: Tachycardia, hypotension, shock Digestive: Abdominal discomfort, diarrhea, nausea, vomiting Hematologic: Blood dyscrasia (thrombocytopenia, leucopenia) Hepatic: Increased transaminases, hepatic dysfunction Musculoskeletal: Muscle spasms.
Growth retardation and bone changes (e.g., metaphyseal dysplasia) Nervous System: Neurological disturbances, including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias, seizures; exacerbation or precipitation of aluminum-related dialysis encephalopathy Special Senses: High-frequency sensorineural hearing loss, tinnitus visual disturbances including acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts Respiratory: Acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates) Skin: Generalized rash Urogenital: Dysuria, acute renal failure, increased serum creatinine, and renal tubular disorders