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Pyrimethamine: Drug information

Pyrimethamine: Drug information
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For additional information see "Pyrimethamine: Patient drug information" and "Pyrimethamine: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Daraprim
Pharmacologic Category
  • Antimalarial Agent
Dosing: Adult
Cystoisosporiasis in patients with HIV

Cystoisosporiasis (formerly Isosporiasis) in patients with HIV (alternative agent) (off-label use):

Note: For patients unable to use sulfa agents (Ref).

Acute infection, treatment: Oral: 50 to 75 mg once daily in combination with leucovorin calcium (Ref).

Chronic maintenance therapy (secondary prophylaxis): Oral: 25 mg once daily in combination with leucovorin calcium (Ref).

Pneumocystis pneumonia in patients with HIV

Pneumocystis pneumonia in patients with HIV (alternative agent) (off-label use):

Prophylaxis, primary or secondary: Oral: 50 or 75 mg once weekly in combination with dapsone and leucovorin calcium. Continue until CD4 count ≥200 cells/mm3 for ≥3 months in response to antiretroviral therapy (ART); may consider discontinuation of prophylaxis in patients with CD4 counts between 100 and 200 cells/mm3 who are receiving ART and have had an undetectable viral load for ≥3 to 6 months (Ref).

Toxoplasmosis

Toxoplasmosis:

Patients with HIV:

Primary prophylaxis (alternative agent) (off-label use): Oral: 50 or 75 mg once weekly in combination with dapsone and leucovorin calcium; or 25 mg once daily in combination with atovaquone and leucovorin calcium. Continue until CD4 count >200 cells/mm3 for >3 months in response to ART and viral load is undetectable; some experts discontinue prophylaxis in patients with CD4 counts between 100 and 200 cells/mm3 who are receiving ART and have had an undetectable viral load for ≥3 to 6 months (Ref).

Encephalitis, treatment: Oral: 200 mg as a single dose, followed by 50 mg once daily (patient weight ≤60 kg) or 75 mg once daily (patient weight >60 kg), in combination with leucovorin calcium and other appropriate agents (eg, atovaquone, clindamycin, or sulfadiazine [preferred]). Duration is for ≥6 weeks (longer if extensive disease or incomplete response) followed by chronic maintenance therapy. Note: If pyrimethamine is unavailable or there is a procurement delay, trimethoprim-sulfamethoxazole should be used in place of pyrimethamine-containing regimens until pyrimethamine is available (Ref).

Chronic maintenance therapy (secondary prophylaxis) (off-label use): Oral: 25 to 50 mg once daily in combination with sulfadiazine and leucovorin calcium; or 25 to 50 mg once daily in combination with clindamycin and leucovorin calcium (alternative regimen); or 25 mg once daily in combination with atovaquone and leucovorin calcium (alternative regimen). May discontinue in patients who remain asymptomatic of signs/symptoms of Toxoplasma gondii encephalitis, and have a CD4 count >200 cells/mm3 for >6 months in response to ART (Ref).

Patients without HIV:

Primary prophylaxis in solid organ transplant recipients (alternative agent) (off-label use): Oral: 50 mg once weekly in combination with dapsone and leucovorin calcium. Primary prophylaxis is often lifelong for donor-seropositive/recipient-seronegative (D+/R-) cardiac recipients, although discontinuation of prophylaxis may be considered with close clinical and laboratory monitoring; prophylaxis may be considered for D+/R- noncardiac recipients with duration dependent on patient-specific factors and/or institutional protocols (Ref).

Treatment: Oral: 50 to 75 mg once daily in combination with a sulfonamide and leucovorin calcium for 1 to 3 weeks depending on patient's tolerance and response, then may reduce dose by 50% and continue for 4 to 5 weeks (Ref).

Solid organ transplant recipients: Oral: 200 mg as a single dose, followed by 50 mg once daily (patient weight <60 kg) or 75 mg once daily (patient weight ≥60 kg), in combination with leucovorin calcium and other appropriate agents (eg, atovaquone, clindamycin, or sulfadiazine [preferred]). Duration is ≥6 weeks, followed by lifelong suppression (Ref).

Chronic suppressive therapy in solid organ transplant recipients (off-label use): Oral: 25 mg (patient weight <60 kg) or 50 mg (patient weight ≥60 kg) once daily in combination with leucovorin calcium and other appropriate agents (eg, atovaquone, clindamycin, sulfadiazine [preferred]) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Pyrimethamine: Pediatric drug information")

Note: Oral leucovorin should be administered throughout the entire course to prevent hematologic toxicity (Ref).

Cystoisosporiasis, HIV-exposed/-infected

Cystoisosporiasis (formerly isosporiasis), HIV-exposed/-infected: Alternative therapy to sulfamethoxazole/trimethoprim.

Treatment :

Infants and Children: Oral: 1 mg/kg/day once daily in combination with leucovorin for 14 days; maximum daily dose: 25 mg/day (Ref).

Adolescents: Oral: 50 to 75 mg once daily in combination with leucovorin (Ref).

Chronic maintenance (secondary prophylaxis):

Infants and Children: Oral: 1 mg/kg/day once daily in combination with leucovorin; maximum daily dose: 25 mg/day (Ref).

Adolescents: Oral: 25 mg once daily in combination with leucovorin (Ref).

Pneumocystis jirovecii pneumonia, HIV-exposed/-infected; primary prophylaxis or chronic maintenance

Pneumocystis jirovecii pneumonia (PCP), HIV-exposed/-infected; primary prophylaxis or chronic maintenance (secondary prophylaxis): Alternative therapy (Ref):

Adolescents: Oral:

In combination with dapsone and leucovorin: 50 to 75 mg once weekly (dose depends on dapsone dose).

In combination with atovaquone and leucovorin: 25 mg once daily.

Toxoplasmosis, acquired infection; treatment

Toxoplasmosis, acquired infection (including encephalitis); treatment:

HIV-exposed/-infected:

Infants and Children: Oral: 2 mg/kg/day (maximum dose: 50 mg/dose) once daily for 3 days followed by 1 mg/kg/day once daily (maximum dose: 25 mg/dose) in combination with leucovorin and either sulfadiazine or clindamycin; treat for at least 6 weeks; consider longer duration if clinical or radiologic disease is extensive or incomplete response; follow with chronic suppressive therapy in patients experiencing encephalitis (Ref).

Adolescents: Oral: Encephalitis: 200 mg once as a single dose, followed by weight-based daily dosing; treat for at least 6 weeks (Ref):

Weight <60 kg: 50 mg once daily.

Weight ≥60 kg: 75 mg once daily.

Non-HIV-exposed/-infected (Ref):

Note: Use in combination with leucovorin and either sulfadiazine or clindamycin.

Infants, Children, and Adolescents:

<60 kg: Oral: Initial: 2 mg/kg/day in divided doses twice daily for 2 days (maximum dose: Chorioretinitis: 25 mg/dose; severe or CNS disease: 50 mg/dose); followed by 1 mg/kg/day once daily (maximum dose: Chorioretinitis: 25 mg/dose; severe or CNS disease: 50 mg/dose). Continue therapy for 1 to 2 weeks after symptom resolution, for a total therapy of 4 to 6 weeks.

≥60 kg: Oral: Initial: 2 mg/kg/day in divided doses twice daily for 2 days (maximum dose: Chorioretinitis: 25 mg/dose; severe or CNS disease: 50 mg/dose); followed by 1 mg/kg/day once daily (maximum dose: Chorioretinitis: 25 mg/dose; severe or CNS disease: 75 mg/dose). Continue therapy for 1 to 2 weeks after symptom resolution, for a total therapy of 4 to 6 weeks.

Toxoplasmosis, congenital infection; treatment

Toxoplasmosis, congenital infection (independent of HIV status); treatment: In combination with sulfadiazine and leucovorin:

Infants: Oral: Initial: 2 mg/kg/day once daily or in 2 divided doses for 2 days, then 1 mg/kg/day once daily for 2 to 6 months, then 1 mg/kg/dose 3 times weekly (eg, Monday, Wednesday, Friday); maximum dose: 25 mg/dose; total treatment duration: 12 months (Ref).

Toxoplasmosis, prophylaxis, in hematopoietic cell transplantation recipients

Toxoplasmosis, prophylaxis, in hematopoietic cell transplantation recipients (Ref):

Infants and Children: Oral: 1 mg/kg/day once daily with clindamycin and leucovorin; maximum dose: 75 mg/dose. Start after engraftment and administer as long as the patient remains on immunosuppressive therapy.

Adolescents: Oral: 25 to 75 mg once daily with clindamycin and leucovorin. Start after engraftment and administer as long as the patient remains on immunosuppressive therapy.

Toxoplasmosis, prophylaxis, in HIV-exposed/-infected patients

Toxoplasmosis, prophylaxis, in HIV-exposed/-infected patients:

Primary prophylaxis: Alternative therapy to sulfamethoxazole/trimethoprim:

Infants and Children (Ref): Oral:

In combination with dapsone and oral leucovorin: 1 mg/kg/day once daily; maximum dose: 25 mg/dose.

In combination with atovaquone and oral leucovorin: Infants and Children 4 to 24 months: 1 mg/kg/day or 15 mg/m2/day once daily; maximum dose: 25 mg/dose.

Adolescents (Ref): Oral:

In combination with dapsone and oral leucovorin: 50 mg or 75 mg once weekly.

In combination with atovaquone and oral leucovorin: 25 mg once daily.

Secondary prophylaxis/suppressive therapy:

Infants and Children: Oral: 1 mg/kg/day or 15 mg/m2/day once daily (maximum dose: 25 mg/dose) with leucovorin and sulfadiazine, clindamycin, or atovaquone (Ref).

Adolescents (Ref): Oral:

In combination with sulfadiazine or clindamycin: 25 to 50 mg once daily plus leucovorin.

In combination with atovaquone: 25 mg once daily plus leucovorin.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified. Reported adverse reactions include combination therapy.

Frequency not defined:

Cardiovascular: Cardiac arrhythmia

Dermatologic: Erythema multiforme

Gastrointestinal: Anorexia, glossitis (atrophic), vomiting

Genitourinary: Hematuria

Hematologic & oncologic: Hematologic abnormality (hyperphenylalaninemia), megaloblastic anemia, neutropenia, pancytopenia

Postmarketing:

Dermatologic: Stevens-Johnson syndrome (Phillips-Howard 1990), toxic epidermal necrolysis (Phillips-Howard 1990)

Hematologic & oncologic: Agranulocytosis (Booth 1984), granulocytopenia (Phillips-Howard 1990), leukopenia (Phillips-Howard 1990), thrombocytopenia (Phillips-Howard 1990)

Hepatic: Hepatic impairment (including hepatitis) (Phillips-Howard 1990)

Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms (Sousa 2016), hypersensitivity reaction (including anaphylaxis, angioedema) (Phillips-Howard 1990)

Nervous system: Seizure (Phillips-Howard 1990)

Ophthalmic: Iritis (Phillips-Howard 1990), toxic amblyopia (Phillips-Howard 1990)

Respiratory: Eosinophilic pneumonitis (Davidson 1988)

Contraindications

Hypersensitivity to pyrimethamine or any component of the formulation; megaloblastic anemia secondary to folate deficiency

Warnings/Precautions

Concerns related to adverse effects:

• Hematologic: Megaloblastic anemia, leukopenia, thrombocytopenia, neutropenia, and pancytopenia have been reported; most commonly with high doses.

Disease-related concerns:

• Folate deficiency: Use caution in patients with possible folate deficiency (eg, malabsorption syndrome, alcoholism).

• G6PD deficiency: Use with caution in patients with possible G6PD deficiency.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment.

• Seizure disorders: Use with caution in patients with a history of seizure disorders.

Other warnings/precautions:

• Leucovorin: Administer leucovorin to prevent hematologic complications due to pyrimethamine-induced folic acid deficiency state; continue leucovorin during therapy and for 1 week after therapy is discontinued (to account for long half-life of pyrimethamine) (HHS [OI pediatric 2019])

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Daraprim: 25 mg [DSC] [scored]

Daraprim: 25 mg [scored; contains corn starch]

Generic: 25 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Daraprim Oral)

25 mg (per each): $900.00

Tablets (Pyrimethamine Oral)

25 mg (per each): $796.88 - $855.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: Administer with meals to minimize GI distress.

Administration: Pediatric

Oral: Administer with meals to minimize loss of appetite and/or vomiting.

Use: Labeled Indications

Toxoplasmosis: Treatment of toxoplasmosis when used in combination with a sulfonamide.

Use: Off-Label: Adult

Cystoisosporiasis (formerly Isosporiasis) in patients with HIV; Pneumocystis pneumonia in patients with HIV, prophylaxis; Toxoplasma gondii encephalitis, prophylaxis

Medication Safety Issues
Sound-alike/look-alike issues:

Daraprim may be confused with Dantrium, Daranide

Metabolism/Transport Effects

Inhibits MATE1/2-K, OCT1, OCT2;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Artemether and Lumefantrine: Antimalarial Agents may increase adverse/toxic effects of Artemether and Lumefantrine. Management: Artemether/lumefantrine (combination product) should not be used with other antimalarials unless there is no other treatment option. If combined, monitor patients for increased toxicities of both agents, including QTc interval prolongation. Risk D: Consider Therapy Modification

ChlorproMAZINE: Antimalarial Agents may increase serum concentration of ChlorproMAZINE. Risk C: Monitor

Clofarabine: OCT2 Inhibitors may increase serum concentration of Clofarabine. Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of Pyrimethamine. Risk C: Monitor

Dalfampridine: OCT2 Inhibitors may increase serum concentration of Dalfampridine. Management: Consider alternatives to this combination. Carefully weigh the risk of seizures against the benefit of combining OCT2 inhibitors with dalfampridine. Risk D: Consider Therapy Modification

Dapsone (Systemic): Antimalarial Agents may increase adverse/toxic effects of Dapsone (Systemic). Specifically, concomitant use of antimalarial agents with dapsone may increase the risk of hemolytic reactions. Dapsone (Systemic) may increase adverse/toxic effects of Antimalarial Agents. Specifically, concomitant use of dapsone with antimalarial agents may increase the risk for hemolytic reactions. Management: Closely monitor patients for signs/symptoms of hemolytic reactions with concomitant use of dapsone and antimalarial agents, particularly in patients deficient in glucose-6-phosphate dehydrogenase (G6PD), methemoglobin reductase, or with hemoglobin M. Risk D: Consider Therapy Modification

Dapsone (Topical): Antimalarial Agents may increase adverse/toxic effects of Dapsone (Topical). Specifically, the risk of hemolytic reactions may be increased. Management: Consider avoidance of this combination when possible. If combined, closely monitor for signs/symptoms of hemolytic reactions. Patients with glucose-6-phosphate dehydrogenase deficiency may be at particularly high risk for adverse hematologic effects. Risk D: Consider Therapy Modification

Dofetilide: MATE1/2-K Inhibitors may increase serum concentration of Dofetilide. Risk X: Avoid

Folic Acid: May decrease therapeutic effects of Pyrimethamine. Management: Folic acid doses greater than 2.5 mg per day should be avoided due to the potential for sulfadoxine/pyrimethamine treatment failure. Consider limiting folic acid use to no more than 0.4 mg per day for women of child-bearing age. Risk D: Consider Therapy Modification

LORazepam: May increase hepatotoxic effects of Pyrimethamine. Risk C: Monitor

MetFORMIN: MATE1/2-K Inhibitors may increase serum concentration of MetFORMIN. Risk C: Monitor

Methotrexate: Pyrimethamine may increase adverse/toxic effects of Methotrexate. Risk C: Monitor

PEMEtrexed: Pyrimethamine may increase adverse/toxic effects of PEMEtrexed. Risk C: Monitor

Phenobarbital-Primidone: May decrease serum concentration of Pyrimethamine. Risk C: Monitor

PRALAtrexate: Pyrimethamine may increase adverse/toxic effects of PRALAtrexate. Risk C: Monitor

Proguanil: Pyrimethamine may increase adverse/toxic effects of Proguanil. Risk C: Monitor

Raltitrexed: Pyrimethamine may increase adverse/toxic effects of Raltitrexed. Risk C: Monitor

Sulfonamide Antibiotics: Pyrimethamine may increase adverse/toxic effects of Sulfonamide Antibiotics. Risk C: Monitor

Trimethoprim: Pyrimethamine may increase adverse/toxic effects of Trimethoprim. Risk C: Monitor

Reproductive Considerations

Pregnancy should be avoided during therapy.

Pregnancy Considerations

Pyrimethamine crosses the placenta (Peytavin 2000).

Pyrimethamine should be used with caution in patients with possible folate deficiency, including pregnant patients. If administered during pregnancy (ie, for toxoplasmosis), supplementation of folate is strongly recommended. Avoid use during the first trimester for indications other than toxoplasmosis due to adverse events observed in animal reproduction studies.

Pyrimethamine is recommended for treatment of T. gondii encephalitis in pregnant patients with HIV. Dosing is the same as in nonpregnant patients. Maternal use of pyrimethamine is also recommended for the treatment of fetal toxoplasmosis infection. Agents other than pyrimethamine are recommended for the management of Pneumocystis pneumonia during pregnancy (HHS [OI adult 2024]).

Breastfeeding Considerations

Pyrimethamine is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made to discontinue breastfeeding or to discontinue the drug, considering the importance of treatment to the mother.

Dietary Considerations

Take with meals.

Monitoring Parameters

CBC, including platelet counts twice weekly with high-dose therapy (eg, when used for toxoplasmosis treatment; frequency not defined for lower doses); hepatic and renal function

Mechanism of Action

Inhibits parasitic dihydrofolate reductase, resulting in inhibition of vital tetrahydrofolic acid synthesis

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Well absorbed

Distribution: Vd: Adults: 2.9 L/kg; distributed to the kidneys, lung, liver, and spleen

Protein binding: 87%

Half-life elimination: 80 to 95 hours (White 1985)

Time to peak, serum: 2 to 6 hours

Excretion: Urine (16% to 32%)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Daraprim;
  • (AR) Argentina: Daraprim | Daraprin;
  • (AT) Austria: Daraprim;
  • (AU) Australia: Daraprim;
  • (BD) Bangladesh: Malomin | Tindurin;
  • (BE) Belgium: Daraprim;
  • (BG) Bulgaria: Daraprim;
  • (BR) Brazil: Daraprim;
  • (CH) Switzerland: Daraprim;
  • (CL) Chile: Daraprim;
  • (CO) Colombia: Daraprim | Pirimetamina;
  • (CZ) Czech Republic: Daraprim;
  • (DE) Germany: Daraprim;
  • (DO) Dominican Republic: Toxopirin;
  • (EE) Estonia: Daraprim;
  • (EG) Egypt: Daraprim;
  • (ES) Spain: Daraprim;
  • (FI) Finland: Daraprim;
  • (FR) France: Daraprim | Malocide | Pyrimethamine Dci;
  • (GB) United Kingdom: Daraprim;
  • (GR) Greece: Daraprim;
  • (HK) Hong Kong: Daraprim;
  • (HU) Hungary: Tindurin;
  • (IE) Ireland: Daraprim;
  • (IL) Israel: Daraprim;
  • (IN) India: Daramin | Daraprim;
  • (JO) Jordan: Daraprim;
  • (JP) Japan: Daraprim;
  • (KE) Kenya: Xoprim;
  • (LT) Lithuania: Daraprim | Tindurin;
  • (LU) Luxembourg: Daraprim;
  • (LV) Latvia: Daraprim | Tindurin;
  • (MX) Mexico: Daraprim | Pirimetamina;
  • (NL) Netherlands: Daraprim;
  • (NO) Norway: Daraprim;
  • (NZ) New Zealand: Daraprim;
  • (PL) Poland: Daraprim | Malocide | Pyrimen;
  • (PR) Puerto Rico: Daraprim;
  • (PT) Portugal: Daraprim | Pirimetamina;
  • (QA) Qatar: Daraprim;
  • (RO) Romania: Daraprim;
  • (RU) Russian Federation: Daraprim;
  • (SA) Saudi Arabia: Daraprim;
  • (SE) Sweden: Daraprim;
  • (SG) Singapore: Daraprim;
  • (SI) Slovenia: Daraprim;
  • (SK) Slovakia: Daraprim;
  • (TH) Thailand: A bin | Daraprim;
  • (TN) Tunisia: Malocide;
  • (TR) Turkey: Daraprim;
  • (TW) Taiwan: Daraprim;
  • (ZA) South Africa: Daraprim
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