Hydroxychloroquine Sulfate

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Hydroxychloroquine Sulfate Prescribing Information

Warnings and Precautions, Risks Associated with Use in Porphyria (

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.

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07/2023

Warnings and Precautions, Neuropsychiatric Reactions Including Suicidality (

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 ].

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.

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07/2023

Hydroxychloroquine sulfate tablets 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 Malaria
Hydroxychloroquine sulfate tablet 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:
Hydroxychloroquine sulfate tablet is
not
recommended for:
- Treatment of complicated malaria.
- Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of
  Plasmodium
  species
  [see Microbiology ].
- 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 ].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention¹.
)
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (
1.1 Malaria
Hydroxychloroquine sulfate tablet 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:
Hydroxychloroquine sulfate tablet is
not
recommended for:
- Treatment of complicated malaria.
- Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of
  Plasmodium
  species
  [see Microbiology ].
- 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 ].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention¹.
)
Treatment of rheumatoid arthritis in adults. (
1 INDICATIONS AND USAGE
Hydroxychloroquine sulfate tablets 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 (1.1):
Hydroxychloroquine sulfate Tablets 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
Hydroxychloroquine sulfate tablet 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:
Hydroxychloroquine sulfate tablet is
not
recommended for:
Treatment of complicated malaria.
Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of
Plasmodium
species
[see Microbiology ].
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 ].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention¹.
1.2 Rheumatoid Arthritis
Hydroxychloroquine sulfate tablet is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults.
)
Treatment of systemic lupus erythematosus in adults. (
1.3 Systemic Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults.
)
Treatment of chronic discoid lupus erythematosus in adults. (
1.4 Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults.
)

Limitations of Use (1.1):

Hydroxychloroquine sulfate Tablets 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.

Malaria in Adult and Pediatric Patients (

2.2 Dosage for Malaria in Adult and Pediatric Patients

Hydroxychloroquine sulfate is not recommended in pediatric patients less than 31 kg because the lowest available strength (200 mg) exceeds the recommended dose for these patients and it cannot be divided.

Prophylaxis

Treatment must start 2 weeks before travel to an endemic area. Advise the patient to take the prophylaxis dosage once a week, staring 2 weeks prior to travel to the endemic area, on the same day every week, continuing the same weekly dose while in the endemic area, and for 4 weeks after leaving the endemic area. The recommended prophylaxis dosage is:

Adult patients: 400 mg once a week
Pediatric patients ≥ 31kg: 6.5 mg/kg actual body weight (up to 400 mg) once a week

Treatment of Uncomplicated Malaria

The dosages for the treatment of uncomplicated malaria are:

Adult patients: Administer 800 mg initially; subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2,000 mg).
Pediatric patients ≥ 31 kg: Administer 13 mg/kg (up to 800 mg) initially; subsequently administer 6.5 mg/kg (up to 400 mg) at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg - up to 2,000 mg).

For radical cure of

P. vivax and P. ovale

infections, concomitant therapy with an 8 -aminoquinoline drug is necessary

[see Microbiology ].

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 (

2.3 Dosage for Rheumatoid Arthritis in Adults

The recommended dosage is:

Initial dosage: 400 mg to 600 mg daily as a single daily dose or two divided doses. The action of hydroxychloroquine is cumulative and may require weeks to months for maximum therapeutic effect. Daily doses exceeding 5 mg/kg (actual weight) of hydroxychloroquine sulfate increase the incidence of retinopathy
[see Warnings and Precautions ].
Chronic dosage: 200 mg once daily to 400 mg daily, as a single dose or two divided doses.

Corticosteroids, salicylates, and other antirheumatic agents may be used concomitantly with hydroxychloroquine sulfate.

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 (

2.4 Dosage for Systemic Lupus Erythematosus in Adults

The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses.

200 mg once daily or 400 mg once daily (or in two divided doses)

Chronic Discoid Lupus Erythematosus in Adults (

2.5 Dosage for Chronic Discoid Lupus Erythematosus in Adults

The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses.

200 mg once daily or 400 mg once daily (or in two divided doses)

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine sulfate 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 hydroxychloroquine sulfate 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% to 4% and 15% to 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 2,500 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 hydroxychloroquine sulfate 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.

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Hydroxychloroquine Sulfate Prescribing Information

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