pharmacopeia
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/api/v1/drug/ritonavir

Boxed warning

DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir [see Contraindications (4) , Warnings and Precautions (5.1) ]. WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS See full prescribing information for complete boxed warning Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir. ( 4 , 5.1 )

Mechanism of action

Sourced from openFDA

Ritonavir is an antiretroviral drug [see Microbiology (12.4) ] .

Breast Cancer Resistance ProteinCytochrome P450 2D6Cytochrome P450 3ACytochrome P450 3A4HIV ProteaseP-Glycoprotein

Indications

Sourced from openFDA
  • Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.ICD-10: B20

Contraindications

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  • When co-administering ritonavir tablets with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. Ritonavir tablets are contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome) to ritonavir or any of its ingredients.contraindicated

Dosage & administration

Sourced from openFDA

Adult patients: 600 mg twice-day with meals ( 2.3 ) Pediatrics patients: The recommended twice daily dose for children greater than one month of age is based on body surface area and should not exceed 600 mg twice daily with meals ( 2.4 ) Ritonavir oral solution should not be administered to neonates before a postmenstrual age (first day of the mother’s last menstrual period to birth plus the time elapsed after birth) of 44 weeks has been attained ( 2.4 , 5.2 ) Ritonavir oral powder can only be used for dosing increments of 100 mg ( 2.4 ) Dose modification for ritonavir tablet is necessary when used with other protease inhibitors ( 2.6 ) 2.1 General Administration Recommendations Ritonavir tablets must be used in combination with other antiretroviral agents. Ritonavir tablets are administered orally. Ritonavir tablets should be swallowed whole, and not chewed, broken or crushed. Take ritonavir tablets with meals. General Dosing Guidelines Patients who take the 600 mg twice daily soft gel capsule ritonavir dose may experience more gastrointestinal side effects such as nausea, vomiting, abdominal pain or diarrhea when switching from the soft gel capsule to the tablet formulation because of greater maximum plasma concentration (C max ) achieved with the tablet formulation relative to the soft gel capsule [see Clinical Pharmacology (12.3) ] . Patients should also be aware that these adverse events (gastrointestinal or paresthesias) may diminish as therapy is continued.

Warnings & precautions

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The following have been observed in patients receiving ritonavir: The concomitant use of ritonavir and certain other drugs may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions. ( 5.1 , 7.2 ) Toxicity in preterm neonates: Ritonavir oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. A safe and effective dose of ritonavir oral solution in this patient population has not been established ( 2.4 , 5.2 ) Hepatotoxicity: Fatalities have occurred. Monitor liver function before and during therapy, especially in patients with underlying hepatic disease, including hepatitis B and hepatitis C, or marked transaminase elevations (5.3 , 8.6) Pancreatitis: Fatalities have occurred; suspend therapy as clinically appropriate (5.4) Allergic Reactions/Hypersensitivity: Allergic reactions have been reported and include anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson syndrome, bronchospasm and angioedema. Discontinue treatment if severe reactions develop (5.5 , 6.2) PR interval prolongation may occur in some patients. Cases of second and third degree heart block have been reported.

Adverse reactions

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The following adverse reactions are discussed in greater detail in other sections of the labeling. Drug Interactions [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Pancreatitis [see Warnings and Precautions (5.4) ] Allergic Reactions/Hypersensitivity [see Warnings and Precautions (5.5) ] When co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions. The most frequently reported adverse drug reactions among patients receiving ritonavir alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults The safety of ritonavir alone and in combination with other antiretroviral agents was studied in 1,755 adult patients.

Use in specific populations

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When co-administering ritonavir with other protease inhibitors, see the full prescribing information for the co-administered protease inhibitor including important information for use in special populations. Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission ( 8.2 ). 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ritonavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1–800–258–4263. Risk Summary Prospective pregnancy data from the Antiretroviral Pregnancy Registry (APR) are not sufficient to adequately assess the risk of birth defects or miscarriage. Available data from the APR show no difference in the rate of overall birth defects for ritonavir compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) [see Data]. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with oral administration of ritonavir to pregnant rats and rabbits. During organogenesis in the rat and rabbit, systemic exposure (AUC) was approximately 1/3 lower than human exposure at the recommended daily dose.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of ritonavir have been studied in healthy volunteers and HIV-infected patients (CD 4 greater than or equal to 50 cells per μL). See Table 5 for ritonavir pharmacokinetic characteristics.

Overdosage

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Acute Overdosage - Human Overdose Experience Human experience of acute overdose with ritonavir is limited. One patient in clinical trials took ritonavir 1500 mg per day for two days. The patient reported paresthesias which resolved after the dose was decreased. A post-marketing case of renal failure with eosinophilia has been reported with ritonavir overdose. The approximate lethal dose was found to be greater than 20 times the related human dose in rats and 10 times the related human dose in mice. Management of Overdosage Ritonavir oral solution contains ethanol and propylene glycol. Ingestion of the product over the recommended dose by a young child could result in significant toxicity and could potentially be lethal. Treatment of overdose with ritonavir consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with ritonavir. If indicated, elimination of unabsorbed drug should be achieved by gastric lavage; usual precautions should be observed to maintain the airway. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug.

Approval history

Sourced from openFDA
  • Sep 15, 2000NDANDA021251Abbvie
  • Oct 28, 2005NDANDA021906Abbvie
  • Feb 10, 2010NDANDA022417Abbvie
  • Jan 15, 2015ANDAANDA202573Cipla
  • Jun 7, 2017NDANDA209512Abbvie
  • Sep 17, 2018ANDAANDA206614Aurobindo Pharma Ltd
  • Sep 17, 2018ANDAANDA208890Amneal
  • May 25, 2023NDANDA217188Pfizer

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
94,062 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Covid-1922,99424%
  2. 2Disease Recurrence20,16421%
  3. 3Dysgeusia7,4998.0%
  4. 4Diarrhoea5,6996.1%
  5. 5Drug Interaction5,0625.4%
  6. 6Nausea4,3444.6%
  7. 7Fatigue3,1613.4%
  8. 8Pain2,9993.2%
  9. 9Foetal Exposure During Pregnancy2,9893.2%
  10. 10Headache2,9463.1%
  11. 11Vomiting2,7973.0%
  12. 12Off Label Use2,6252.8%
  13. 13Pyrexia2,5592.7%
  14. 14Cough2,3502.5%
  15. 15Anxiety2,2142.4%

Literature

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Recent PubMed references pinned to Ritonavir as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,179 ClinicalTrials.gov registrations naming Ritonavir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ritonavir work?
Ritonavir is an antiretroviral drug [see Microbiology (12.4) ] .
What is Ritonavir used for?
According to FDA labeling, Ritonavir carries indications including: Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ritonavir?
Ritonavir is classified as Protease inhibitors, Cytochrome P450 3A Inhibitor, Protease Inhibitor, Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 1A2 Inducers, Cytochrome P450 2B6 Inducers, Cytochrome P450 2C19 Inducers, Cytochrome P450 2C9 Inducers, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A Inducers, Cytochrome P450 3A Inhibitors, Cytochrome P450 3A4 Inhibitors, HIV Protease Inhibitors, P-Glycoprotein Inhibitors, UDP Glucuronosyltransferases Inducers, Decreased Protein Synthesis, Increased Immunologically Active Molecule Activity.
What are the brand names for Ritonavir?
Ritonavir is marketed under brand names including Kaletra, Norvir.
What are the contraindications for Ritonavir?
Ritonavir labeling lists contraindications including: When co-administering ritonavir tablets with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. Ritonavir tablets are contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome) to ritonavir or any of its ingredients.. Always consult the full prescribing information and a clinician.
Note. Data for ritonavir is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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