Hydroxychloroquine Sulfate (Page 2 of 5)

5.3 Serious Skin Reactions

Serious adverse reactions have been reported with the use of hydroxychloroquine sulfate 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 (5.4,5.5), Adverse Reactions (6)]. Discontinue hydroxychloroquine sulfate if these severe reactions occur.

5.4 Worsening of Psoriasis

Administration of hydroxychloroquine sulfate to patients with psoriasis may precipitate a severe flare-up of psoriasis. Avoid hydroxychloroquine sulfate in patients with psoriasis, unless the benefit to the patient outweighs the possible risk.

5.5 Risks Associated with Use in Porphyria

Administration of hydroxychloroquine sulfate to patients with porphyria may exacerbate porphyria. Avoid hydroxychloroquine sulfate in patients with porphyria.
Hepatotoxicity Associated with Porphyria Cutanea Tarda
Cases of hepatotoxicity have been reported when hydroxychloroquine was used in patients with porphyria cutanea tarda (PCT). Patients received dosages ranging from 200 mg twice weekly to 400 mg daily. Most of the PCT-related cases presented with marked elevations in transaminases (>20 times upper limit of the reference range) within days to a month of hydroxychloroquine initiation. In some cases, PCT was diagnosed only after the occurrence of treatment-induced liver injury, when hydroxychloroquine was prescribed for an approved indication. Some of the cases were associated with other risk factors for hepatic injury (e.g., alcohol use, concomitant hepatotoxic medications).
Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, rash, nausea, dark urine, or jaundice. In this clinical context, if the patient is found to have abnormal serum liver tests (e.g., ALT level greater than three times the upper limit of the reference range, total bilirubin greater than two times the upper limit of the reference range), interrupt treatment with hydroxychloroquine sulfate, and investigate further to establish the probable cause.
The safety and effectiveness of hydroxychloroquine sulfate for the treatment of PCT have not been established and hydroxychloroquine sulfate is not approved for this use.

5.6 Hematologic Toxicity

Hydroxychloroquine sulfate may cause myelosuppression including aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia. Monitor blood cell counts periodically in patients on prolonged hydroxychloroquine sulfate therapy. If the patient develops myelosuppression which cannot be attributable to the disease, discontinue the drug.

5.7 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.

5.8 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 [see Warnings and Precautions (5.1, 5.11)].

Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with hydroxychloroquine sulfate. Discontinue hydroxychloroquine sulfate if muscle or nerve toxicity is suspected or demonstrated by tissue biopsy.

5.9 Neuropsychiatric Reactions Including Suicidality

Suicidal behavior, suicidal ideation, and other neuropsychiatric adverse reactions have been reported in patients treated with hydroxychloroquine sulfate [see Adverse Reactions (6)]. Neuropsychiatric adverse reactions typically occurred within the first month after
the start of treatment with hydroxychloroquine and have been reported in patients with and without a prior history of psychiatric disorders.
The risks and benefits of continued treatment with hydroxychloroquine sulfate should be assessed for patients who develop these symptoms. Given the long half-life of the drug, some patients may require several weeks off drug for symptoms to partially or fully abate.
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.

5.10 Hypoglycemia

Hydroxychloroquine sulfate 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 hydroxychloroquine sulfate-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.

5.11 Renal Toxicity

Proteinuria with or without moderate reduction in glomerular filtration rate have been reported with the use of hydroxychloroquine sulfate.

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 hydroxychloroquine sulfate. Drug induced phospholipidosis may occur in other organ systems [see Warnings and Precautions (5.1, 5.8)]. Discontinue hydroxychloroquine sulfate if renal toxicity is suspected or demonstrated by tissue biopsy.

6 ADVERSE REACTIONS

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 [see Warnings and Precautions (5.4)]
  • Risks Associated with Use in Porphyria [see Warnings and Precautions (5.5)]
  • Hematologic Toxicity [see Warnings and Precautions (5.6)]
  • Hemolytic Anemia Associated with G6PD [see Warnings and Precautions (5.7)]
  • Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions (5.8)]
  • Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions (5.9)]
  • Hypoglycemia [see Warnings and Precautions (5.10)]
  • Renal Toxicity[see Warnings and Precautions (5.11)]

The following adverse reactions have been identified during post-approval use of 4- aminoquinoline drugs, including hydroxychloroquine sulfate. 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)

Neuro psychiatric disorders: Affect/emotional lability, irritability, nervousness, psychosis, suicidal ideation, suicidal behavior, depression, hallucinations, anxiety, agitation, confusion, delusions, paranoia, mania and sleep disorders (insomnia, night terrors, nightmares)

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)

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