SOVUNA (hydroxychloroquine sulfate)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Congenital long QT syndrome
Prolonged QT interval
Torsades de pointes

There are 9 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic heart failure
Hemolytic anemia from pyruvate kinase and g6PD deficiencies
Hypokalemia
Hypomagnesemia
Maculopathy
Porphyria
Psoriasis
Suicidal ideation
Visual field defect

There are 11 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Alcohol use disorder
Anemia
Disease of liver
Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
Hypoglycemic disorder
Kidney disease with reduction in glomerular filtration rate (GFr)
Myasthenia gravis
Neutropenic disorder
Psychiatric disorder
Seizure disorder
Thrombocytopenic disorder

There are 52 severe adverse reactions.

More Frequent	Less Frequent
None.	Corneal opacity Retinal disorder

Rare/Very Rare

Abnormal hepatic function tests Acquired dystonia Acute generalized exanthematous pustulosis Acute hepatic failure Agranulocytosis Anemia Angioedema Aplastic anemia Atrioventricular block Bronchospastic pulmonary disease Bundle branch block Cardiomyopathy Corneal deposits Corneal edema DRESS syndrome Drug-induced hepatitis Drug-induced phospholipidosis Drug-induced psychosis Dyskinesia Erythema multiforme Exfoliative dermatitis Extrapyramidal disease Hallucinations Hearing loss Heart failure Hepatocellular damage Hypoglycemic disorder Leukopenia Maculopathy Manic disorder Mood changes Muscle atrophy Muscle weakness Myopathy Peripheral motor neuropathy Pigmentary retinopathy Prolonged PR interval Prolonged QT interval Pulmonary hypertension Seizure disorder Skin photosensitivity Stevens-johnson syndrome Suicidal Thrombocytopenic disorder Torsades de pointes Toxic epidermal necrolysis Urticaria Ventricular arrhythmias Ventricular tachycardia Visual field defect

There are 39 less severe adverse reactions.

More Frequent	Less Frequent
None.	Accommodation disorder Alopecia Anorexia Blurred vision Diarrhea Dizziness Dyschromia Headache disorder Nausea Nervousness Pruritus of skin Skin rash Vomiting

Rare/Very Rare
Acquired chromatopsia Acute abdominal pain Acute cognitive impairment Agitation Ataxia Delirium Delusional disorder Depression Drug-exacerbated psoriasis Fatigue Hair discoloration Hyporeflexia Irritability Night blindness Nightmares Nystagmus Photophobia Proteinuria Skin pigmentation enhancement Sleep disorder Symptoms of anxiety Tinnitus Tremor Vertigo Visual changes Weight loss

The manufacturer states that decades of clinical experience with hydroxychloroquine and data available from published epidemiologic and clinical studies of the drug in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus during pregnancy. Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth.

Published data suggest that increased disease activity in pregnant women with rheumatoid arthritis is associated with a risk of adverse pregnancy outcomes, including preterm delivery (before 37 weeks of gestation), low birth weight infants (less than 2.5 kg), and small for gestational age at birth. 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, and passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. Hydroxychloroquine readily crosses the placenta with cord blood concentrations corresponding to maternal plasma concentrations.

The manufacturer states that, although epidemiologic and clinical studies have methodological limitations including small sample size and study design, no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero. CDC states that pregnancy is not a contraindication to use of hydroxychloroquine when the drug is indicated for prevention of malaria. In addition, CDC states that recommendations for use of hydroxychloroquine for the treatment of uncomplicated malaria in pregnant women are the same as those for other patients. There is a pregnancy registry to monitor pregnancy outcomes in women exposed to hydroxychloroquine during pregnancy, and patients should be encouraged to enroll in the registry by calling 877-311-8972.

Hydroxychloroquine is distributed into human milk in low concentrations. It is not known whether the drug has any effects on milk production. The manufacturer states that no adverse reactions have been reported in breast-fed infants of mothers who received hydroxychloroquine and no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine through breast milk.

The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for hydroxychloroquine and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition. CDC states that the amount of drug present in human milk is insufficient to provide adequate protection against malaria in breast-feeding infants. If prevention of malaria is necessary, such infants should receive recommended dosages of appropriate antimalarial agent(s).

No enhanced Geriatric Use information available for this drug.