Hydroxychloroquine

PLAQUENIL 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: PLAQUENIL 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.

Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of PLAQUENIL in the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus and systemic lupus erythematosus are not fully known.

Malaria in Adult and Pediatric Patients: Prophylaxis: Begin weekly doses 2 weeks prior to travel to the endemic area, continue weekly doses while in the endemic area, and continue the weekly doses for 4 weeks after leaving the endemic area: - Adults: 400 mg once a week - Pediatric patients ≥ 31 kg: 6.5 mg/kg up to 400 mg, once a week Treatment of Uncomplicated Malaria: See Full Prescribing Information (FPI) for complete dosing information. Rheumatoid Arthritis in Adults: Initial dosage: 400 mg to 600 mg daily Chronic dosage: 200 mg once daily or 400 mg once daily (or in two divided doses) Systemic Lupus Erythematosus in Adults: 200 mg once daily or 400 mg once daily (or in two divided doses) Chronic Discoid Lupus Erythematosus in Adults: 200 mg once daily or 400 mg once daily (or in two divided doses)

PLAQUENIL is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. • Patients with hypersensitivity to 4-aminoquinoline compounds

• Cardiomyopathy and Ventricular Arrhythmias: Fatal or life-threatening cardiomyopathy and ventricular arrhythmias were reported. • Retinal Toxicity: Irreversible retinal damage is related to cumulative dosage and treatment duration. Baseline retinal exam and exams during treatment are recommended. • Serious Skin Reactions: Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis have been reported. • Worsening of Psoriasis: Avoid in patients with psoriasis. • Risks Associated with Use in Porphyria: Avoid in patients with porphyria. Hepatotoxicity was reported in patients with porphyria cutanea tarda. • Hematologic Toxicity: Discontinue if myelosuppression occurs.

The following adverse reactions are described in greater detail in other sections: • Cardiomyopathy and Ventricular Arrhythmias • Retinal Toxicity • Serious Skin Reactions • Worsening of Psoriasis • Risks Associated with Use in Porphyria • Hematologic Toxicity • Hemolytic Anemia Associated with G6PD • Skeletal Muscle Myopathy or Neuropathy • Neuropsychiatric Reactions Including Suicidality • Hypoglycemia • Renal Toxicity The following adverse reactions have been identified during post-approval use of 4-aminoquinoline drugs, including PLAQUENIL.

• Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs. • See FPI for more important drug interactions. Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs PLAQUENIL prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if PLAQUENIL is used concomitantly with other arrhythmogenic drugs. Therefore, PLAQUENIL is not recommended in patients taking other drugs that have the potential to prolong the QT interval or are arrhythmogenic. Insulin or Other Antidiabetic Drugs PLAQUENIL may enhance the effects of insulin and antidiabetic drugs, and consequently increase the hypoglycemic risk. Therefore, a decrease in dosage of insulin and other antidiabetic drugs may be necessary. Drugs that Lower the Seizure Threshold PLAQUENIL can lower the seizure threshold.

Store at room temperature up to 30°C (86°F) and allow for excursions between 15°C and 30°C (59°F and 86°F). Storage Dispense in a tight, light-resistant container as defined in the USP/NF.