INDICATIONS AND USAGE
SOVUNA is an antimalarial and antirheumatic indicated for the:
- Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients.
- Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients.
- Treatment of rheumatoid arthritis in adults.
- Treatment of systemic lupus erythematosus in adults.
- Treatment of chronic discoid lupus erythematosus in adults.
LIMITATIONS OF USE
SOVUNA is not recommended for the:
- Treatment of complicated malaria.
- Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species.
- Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
- Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
- Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites.
For radical cure of P. vivax or P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: SOVUNA is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.
WARNINGS AND PRECAUTIONS
Cardiomyopathy and Ventricular Arrhythmias: Fatal and life-threatening cases of cardiotoxicity, including cardiomyopathy, have been reported in patients treated with SOVUNA. Signs and symptoms of cardiac compromise have occurred during acute and chronic SOVUNA treatment. In multiple cases, endomyocardial biopsy showed association of the cardiomyopathy with phospholipidosis in the absence of inflammation, infiltration, or necrosis. Drug-induced phospholipidosis may occur in other organ systems.
Patients may present with ventricular hypertrophy, pulmonary hypertension and conduction disorders including sick sinus syndrome. ECG findings include atrioventricular, right or left bundle branch block.
SOVUNA has a potential to prolong the QT interval. Ventricular arrhythmias (including torsades de pointes) have been reported in SOVUNA-treated patients. The magnitude of QT prolongation may increase with increasing concentrations of the drug. The recommended dose should not be exceeded.
Avoid SOVUNA in patients with congenital or documented acquired QT prolongation and/or known risk factors for prolongation of the QT interval. SOVUNA is not recommended in patients taking other drugs that have the potential to prolong the QT interval. Correct electrolyte imbalances prior to use. Monitor cardiac function as clinically indicated during SOVUNA therapy. Discontinue SOVUNA if cardiotoxicity is suspected or demonstrated by tissue biopsy.
Retinal Toxicity: Irreversible retinal damage was observed in some patients treated with hydroxychloroquine sulfate related to cumulative dosage and treatment duration. Risk factors for retinal damage include daily hydroxychloroquine sulfate dosages ≥5 mg/kg of actual body weight, durations of use greater than five years, renal impairment, use of concomitant drug products such as tamoxifen citrate, and concurrent macular disease. Baseline retinal exam within the first year of treatment and annual exams while the patient is on treatment with SOVUNA are recommended. If ocular toxicity is suspected, discontinue SOVUNA and monitor the patient closely given that retinal changes and visual disturbances may progress even after cessation of therapy.
Serious Skin Reactions: Serious adverse reactions have been reported with the use of SOVUNA including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP). Monitor for serious skin reactions, especially in patients receiving a drug that may also induce dermatitis. Advise patients to seek medical attention promptly if they experience signs and symptoms of serious skin reactions such as blisters on the skin, eyes, lips or in the mouth, itching or burning, with or without fever. Discontinue SOVUNA if these severe reactions occur.
Worsening of Psoriasis: Administration of SOVUNA to patients with psoriasis may precipitate a severe flare-up of psoriasis. Avoid SOVUNA in patients with psoriasis unless the benefit to the patient outweighs the possible risk.
Risks Associated with Use in Porphyria: Administration of SOVUNA in patients with porphyria may exacerbate porphyria and should be avoided.
Hematologic Toxicity: SOVUNA may cause myelosuppression including aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia. Monitor blood cell counts periodically in patients on prolonged SOVUNA therapy. If the patient develops myelosuppression which cannot be attributable to the disease, discontinue the drug.
Hemolytic Anemia Associated with G6PD Deficiency: Hemolysis has been reported in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Monitor for hemolytic anemia as this can occur, particularly in association with other drugs that cause hemolysis.
Skeletal Muscle Myopathy or Neuropathy: Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported. Muscle and nerve biopsies have shown associated phospholipidosis. Drug-induced phospholipidosis may occur in other organ systems. Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with SOVUNA. Discontinue SOVUNA if muscle or nerve toxicity is suspected or demonstrated by tissue biopsy.
Neuropsychiatric Reactions Including Suicidality: Suicidal behavior, suicidal ideation, and other neuropsychiatric adverse reactions have been reported in patients treated with SOVUNA. Advise patients to contact their healthcare provider promptly if they experience new or worsening neuropsychiatric symptoms such as depression, suicidal thoughts or behavior, or mood changes.
Hypoglycemia: SOVUNA can cause severe and potentially life-threatening hypoglycemia, in the presence or absence of antidiabetic agents. Measure blood glucose in patients presenting with clinical symptoms suggestive of hypoglycemia and adjust the antidiabetic treatment as necessary. Warn SOVUNA-treated patients about the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia; diabetic patients should monitor their blood sugar levels. Advise patients to seek medical attention if they develop any signs and symptoms of hypoglycemia.
Renal Toxicity: Proteinuria with or without moderate reduction in glomerular filtration rate have been reported with the use of SOVUNA. Renal biopsy showed phospholipidosis without immune deposits, inflammation, and/or increased cellularity. Physicians should consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders who are receiving SOVUNA. Drug-induced phospholipidosis may occur in other organ systems. Discontinue SOVUNA if renal toxicity is suspected or demonstrated by tissue biopsy.
ADVERSE REACTIONS
The most common adverse reactions reported are nausea, vomiting, diarrhea, and abdominal pain.
To report Adverse Reactions you may contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For medical inquiries please call 1-855-204-1431 or email [email protected].
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