This information is not for clinical use. These highlights do not include all the information needed to use Plaquenil safely and effectively. Before taking Plaquenil please consult with your doctor. See full prescribing information for Plaquenil.
Indications And Usage
1 INDICATIONS & USAGE 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. (1.1) • Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients (1.1) • Treatment of rheumatoid arthritis in adults. (1.2) • Treatment of systemic lupus erythematosus in adults. (1.3) • Treatment of chronic discoid lupus erythematosus in adults. (1.4) Limitations of Use (1.1): 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. • 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 and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary. 1.1 Malaria PLAQUENIL is indicated in adult and pediatric patients for the: • Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale. • Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use: PLAQUENIL is not recommended for: • Treatment of complicated malaria. • Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium species [see Microbiology (12.4) ] • 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 and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology (12.4) ] . For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention 1. 1.2 Rheumatoid Arthritis PLAQUENIL is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. 1.3 Systemic Lupus Erythematosus PLAQUENIL is indicated for the treatment of systemic lupus erythematosus in adults. 1.4 Chronic Discoid Lupus Erythematosus PLAQUENIL is indicated for the treatment of chronic discoid lupus erythematosus in adults.
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Dosage Forms And Strengths
3 DOSAGE FORMS & STRENGTHS Tablets: 200 mg of hydroxychloroquine sulfate, white to off-white, film-coated tablet imprinted with “PLAQUENIL” on one face in black ink. Tablets: 200 mg of hydroxychloroquine sulfate
PLAQUENIL is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds • Patients with hypersensitivity to 4-aminoquinoline compounds ( 4 )
Warning and Cautions
• Cardiomyopathy and Ventricular Arrhythmias : Fatal or life-threatening cardiomyopathy and ventricular arrhythmias were reported. (5.1) • Retinal Toxicity : Irreversible retinal damage is related to cumulative dosage and treatment duration. Baseline retinal exam and exams during treatment are recommended. (5.2) • Serious Skin Reactions : Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis have been reported. (5.3) • Worsening of Psoriasis and Porphyria : Avoid in patients with psoriasis or porphyria. (5.4) • Hematologic Toxicity: Discontinue if myelosuppression occurs. (5.5) 5.1 Cardiomyopathy and Ventricular Arrhythmias Fatal and life-threatening cases of cardiotoxicity, including cardiomyopathy, have been reported in patients treated with PLAQUENIL. Signs and symptoms of cardiac compromise have occurred during acute and chronic PLAQUENIL treatment. 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. PLAQUENIL has a potential to prolong the QT interval. Ventricular arrhythmias (including torsades de pointes) have been reported in PLAQUENIL-treated patients. The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded [see Adverse Reactions (6), Overdosage (10)] . Avoid PLAQUENIL administration in patients with congenital or documented acquired QT prolongation and/or known risk factors for prolongation of the QT interval such as: • Cardiac disease, e.g., heart failure, myocardial infarction. • Proarrhythmic conditions, e.g., bradycardia (< 50 bpm). • History of ventricular dysrhythmias. • Uncorrected hypokalemia and/or hypomagnesemia. • Concomitant administration with QT interval prolonging agents [see Drug Interactions (7.1)] as this may lead to an increased risk for ventricular arrhythmias. Therefore, PLAQUENIL is not recommended in patients taking other drugs that have the potential to prolong the QT interval. Monitor cardiac function as clinically indicated during PLAQUENIL therapy. Correct electrolyte imbalances prior to use. Discontinue PLAQUENIL if cardiotoxicity is suspected. 5.2 Retinal Toxicity Irreversible retinal damage was observed in some patients treated with hydroxychloroquine sulfate and it is related to cumulative dosage and treatment duration. In patients of Asian descent, retinal toxicity may first be noticed outside the macula. 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. Within the first year of starting PLAQUENIL, a baseline ocular examination is recommended including best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT). For patients at higher risk of retinal damage, monitoring should include annual examinations which include BCVA, VF and SD-OCT. For patients without significant risk factors, annual retinal exams can usually be deferred until five years of treatment. In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees. If ocular toxicity is suspected, discontinue PLAQUENIL and monitor the patient closely given that retinal changes and visual disturbances may progress even after cessation of therapy. 5.3 Serious Skin Reactions Serious adverse reactions have been reported with the use of PLAQUENIL 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 [see Warnings and Precautions (5.4) , Adverse Reactions (6) ] . Discontinue PLAQUENIL if these severe reactions occur. 5.4 Worsening of Psoriasis and Porphyria Administration of PLAQUENIL in patients with psoriasis may precipitate a severe flare-up of psoriasis. Administration of PLAQUENIL in patients with porphyria may exacerbate porphyria. Avoid PLAQUENIL in patients with psoriasis or porphyria, unless the benefit to the patient outweighs the possible risk. 5.5 Hematologic Toxicity PLAQUENIL may cause myelosuppression including aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia. Monitor blood cell counts periodically in patients on prolonged PLAQUENIL therapy. If the patient develops myelosuppression which cannot be attributable to the disease, discontinue the drug. 5.6 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. 5.7 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 demonstrated bodies and muscle fiber atrophy with vacuolar changes. Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with PLAQUENIL. If weakness occurs, discontinue the drug. 5.8 Neuropsychiatric Reactions Including Suicidality Suicidal behavior has been reported in patients treated with PLAQUENIL [see Adverse Reactions (6) ]. Alert patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or behavior, or mood changes. The risk and benefit of continued treatment with PLAQUENIL should be assessed for patients who develop these symptoms. 5.9 Hypoglycemia PLAQUENIL can cause severe and potentially life-threatening hypoglycemia, in the presence or absence of antidiabetic agents [see Drug Interactions (7) ]. Measure blood glucose in patients presenting with clinical symptoms suggestive of hypoglycemia and as adjust the antidiabetic treatment as necessary. Warn PLAQUENIL-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.
The following adverse reactions are described in greater detail in other sections: • Cardiomyopathy and Ventricular Arrhythmias [see Warnings and Precautions (5.1) ] • Retinal Toxicity [see Warnings and Precautions (5.2) ] • Serious Skin Reactions [see Warnings and Precautions (5.3) ] • Worsening of Psoriasis and Porphyria [see Warnings and Precautions (5.4) ] • Hematologic Toxicity [see Warnings and Precautions (5.5) ] • Hemolytic Anemia Associated with G6PD [see Warnings and Precautions (5.6)] • Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions (5.7) ] • Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions (5.8) ] • Hypoglycemia [see Warnings and Precautions (5.9)] The following adverse reactions have been identified during post-approval use of 4-aminoquinoline drugs, including PLAQUENIL. Because these reactions are 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: - Blood and lymphatic system disorders: Bone marrow depression, anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia - Cardiac disorders: Cardiomyopathy, cardiac failure, QT-interval prolongation, ventricular tachycardia, torsades de pointes, atrioventricular block, bundle branch block, sick sinus syndrome, pulmonary hypertension - Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, sensorineural hearing loss - Eye disorders: Retinopathy, retinal pigmentation changes (typically bull’s eye appearance), visual field defects (paracentral scotomas), macular degeneration, corneal edema, corneal opacities, decreased dark adaptation - Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain - General disorders: Fatigue - Hepatobiliary disorders: Abnormal liver function tests, fulminant hepatic failure - Immune system disorders: Urticaria, angioedema, bronchospasm - Metabolism and nutrition disorders: Anorexia, hypoglycemia, weight loss - Musculoskeletal and connective tissue disorders: Proximal myopathy, depressed tendon reflexes, abnormal nerve conduction - Nervous system disorders: Ataxia, dizziness, headache, seizure, extrapyramidal disorders (dystonia, dyskinesia, tremor) - Psychiatric disorders : Affect/emotional lability, irritability, nervousness, nightmares, psychosis, suicidal ideation, suicidal behavior - Skin and subcutaneous tissue disorders: Alopecia, hair color changes, rash, pruritus, photosensitivity, psoriasis exacerbation, hyperpigmentation, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain (6) To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs. ( 7.1 ) • See FPI for more important drug interactions.( 7 ) 7.1 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 [see Warnings and Precautions (5.1)]. 7.2 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 [see Warnings and Precautions (5.8) ]. 7.3 Drugs that Lower the Seizure Threshold PLAQUENIL can lower the seizure threshold. Co-administration of PLAQUENIL with other antimalarials known to lower the seizure threshold (e.g., mefloquine) may increase the risk of seizures. 7.4 Antiepileptics The activity of antiepileptic drugs might be impaired if co-administered with PLAQUENIL. 7.5 Methotrexate Concomitant use of PLAQUENIL and methotrexate may increase the incidence of adverse reactions. 7.6 Cyclosporine An increased plasma cyclosporin level was reported when cyclosporin and PLAQUENIL were co-administered. Monitor serum cyclosporine levels closely in patients receiving combined therapy. 7.7 Digoxin Concomitant PLAQUENIL and digoxin therapy may result in increased serum digoxin levels. Monitor serum digoxin levels closely in patients receiving combined therapy. 7.8 Cimetidine Concomitant use of cimetidine resulted in a 2-fold increase of exposure of chloroquine, which is structurally related to hydroxychloroquine. Interaction of cimetidine with hydroxychloroquine cannot be ruled out. Avoid concomitant use of cimetidine 7.9 Rifampicin Lack of efficacy of hydroxychloroquine was reported when rifampicin was concomitantly administered. Avoid concomitant use of rifampicin 7.10 Praziquantel Chloroquine has been reported to reduce the bioavailability of praziquantel. Interaction of praziquantel with hydroxychloroquine cannot be ruled out. 7.11 Antacids and kaolin Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed. Interaction of antacids and kaolin with hydroxychloroquine cannot be ruled out. 7.12 Ampicillin In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin. Interaction of ampicillin with hydroxychloroquine cannot be ruled out.
Use In Specific Populations
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to PLAQUENIL during pregnancy. Encourage patients to register by contacting 1-877-311-8972. Risk Summary Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with PLAQUENIL use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see Data ). There are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see Clinical Considerations ). Animal reproduction studies were not conducted with hydroxychloroquine. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Malaria: Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth. Rheumatoid Arthritis: Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Systemic Lupus Erythematosus: Pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction. Passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. Data Human Data Data from published epidemiologic and clinical studies have not established an association with PLAQUENIL use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels. No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero . Available epidemiologic and clinical studies have methodological limitations including small sample size and study design. 8.2 Lactation Risk Summary Published lactation data report that hydroxychloroquine is present in human milk at low levels. No adverse reactions have been reported in breastfed infants. No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine through breastmilk. There is no information on the effect of hydroxychloroquine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PLAQUENIL and any potential adverse effects on the breastfed child from PLAQUENIL or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of PLAQUENIL have been established in pediatric patients for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. vivax , and P. ovale , as well as for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. However, this product cannot be directly administered to pediatric patients weighing less than 31 kg because the film-coated tablets cannot be crushed or divided [see Dosage and Administration (2.1, 2.2) ] . The safety and effectiveness of PLAQUENIL have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus. 8.5 Geriatric Use Clinical trials of PLAQUENIL did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Nevertheless, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. In general, dose selection in geriatric patients should start with the lowest recommended dose, taking into consideration the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. 8.6 Patients with Renal or Hepatic Disease A reduction in the dosage of PLAQUENIL may be necessary in patients with hepatic or renal disease.