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Norvir
Generic Name: Ritonavir
Drug Category: HIV-1 Protease Inhibitor
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 1 month old for a maximum duration of 3 years.
| Approved Uses |
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Indicated for: • NORVIR tablets and oral solution are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. • NORVIR oral powder is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection. NORVIR must be used in combination with other antiretroviral agents. Co-administration of NORVIR 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 NORVIR on the hepatic metabolism of these drugs. Review medications taken by patients prior to prescribing NORVIR or when prescribing other medications to patients already taking NORVIR. Because NORVIR oral solution contains ethanol and propylene glycol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility. NORVIR 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. NORVIR oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. However, if the benefit of using NORVIR oral solution to treat HIV infection in infants immediately after birth outweighs the potential risks, infants should be monitored closely for increases in serum osmolality and serum creatinine, and for toxicity related to NORVIR oral solution including: hyperosmolality, with or without lactic acidosis, renal toxicity, CNS depression (including stupor, coma, and apnea), seizures, hypotonia, cardiac arrhythmias and ECG changes, and hemolysis. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. Hepatic transaminase elevations exceeding 5 times the upper limit of normal, clinical hepatitis, and jaundice have occurred in patients receiving NORVIR alone or in combination with other antiretroviral drugs. There may be an increased risk for transaminase elevations in patients with underlying hepatitis B or C. Therefore, caution should be exercised when administering NORVIR to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Pancreatitis has been observed in patients receiving NORVIR therapy, including those who developed hypertriglyceridemia. In some cases fatalities have been observed. Ritonavir prolongs the PR interval in some patients. Post marketing cases of second or third degree atrioventricular block have been reported in patients. NORVIR should be used with caution in patients with underlying structural heart disease, preexisting conduction system abnormalities, ischemic heart disease, cardiomyopathies, as these patients may be at increased risk for developing cardiac conduction abnormalities. Treatment with NORVIR therapy alone or in combination with saquinavir has resulted in substantial increases in the concentration of total cholesterol and triglycerides. New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported during postmarketing surveillance in HIV infected patients receiving protease inhibitor therapy. Immune reconstitution syndrome has been reported in HIV-infected patients treated with combination antiretroviral therapy, including NORVIR. Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment. There have been reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis, in patients with hemophilia type A and B treated with protease inhibitors. Allergic reactions including urticaria, mild skin eruptions, bronchospasm, and angioedema have been reported. Cases of anaphylaxis, toxic epidermal necrolysis (TEN), and Stevens-Johnson syndrome have also been reported. Varying degrees of cross-resistance among protease inhibitors have been observed. Continued administration of ritonavir 600 mg twice daily following loss of viral suppression may increase the likelihood of cross-resistance to other protease inhibitors. When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. NORVIR is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome) to ritonavir or any of its ingredients. NORVIR is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions:
NORVIR is contraindicated with drugs that are potent CYP3A inducers where significantly reduced ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance:
It is not recommended to co-administer ritonavir with simeprevir. Concurrent administration of salmeterol and ritonavir is not recommended. Do not use ritonavir with avanafil because a safe and effective avanafil dosage regimen has not been established. Avoid use of ADCIRCA during the initiation of ritonavir. Stop ADCIRCA at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume ADCIRCA at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability. Saquinavir/ritonavir in combination with rifampin is not recommended due to the risk of severe hepatotoxicity (presenting as increased hepatic transaminases) if the three drugs are given together. Avoid use of venetoclax or ibrutinib with NORVIR because NORVIR is a strong CYP3A inhibitor and may increase the risk of tumor lysis syndrome. For vincristine and vinblastine, consideration should be given to temporarily withholding the ritonavir containing antiretroviral regimen in patients who develop significant hematologic or gastrointestinal side effects when ritonavir is administered concurrently with vincristine or vinblastine. Avoid concomitant use of rivaroxaban and ritonavir. Co-administration of ritonavir and rivaroxaban may lead to risk of increased bleeding. Discontinue use of bosentan at least 36 hours prior to initiation of ritonavir. After at least 10 days following the initiation of ritonavir, resume bosentan at 62.5 mg once daily or every other day based upon individual tolerability. Risk of significant adverse drug-drug interactions between quetiapine (Seroquel), and HIV protease inhibitors. Careful monitoring of therapeutic and adverse effects (including potentially fatal respiratory depression) is recommended when fentanyl is concomitantly administered with NORVIR. Dosage increase and long-term use of meperidine with ritonavir are not recommended due to the increased concentrations of the metabolite normeperidine which has both analgesic activity and CNS stimulant activity (e.g., seizures). High doses of ketoconazole or itraconazole (greater than 200 mg per day) are not recommended. Consider alternative antiretroviral therapy to avoid increases in quetiapine exposures. If co-administration is necessary, reduce the quetiapine dose to 1/6 of the current dose and monitor for quetiapine-associated adverse reactions. Use of NORVIR may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. NORVIR is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions. NORVIR is contraindicated with drugs that are potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance. Co-administration with corticosteroids whose exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression. NORVIR oral solution is not recommended during pregnancy because there is no known safe level of ethanol exposure during pregnancy. The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. |
| Off-label Uses |
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• Chronic hepatitis B. GoToSource • Use in patients under the age of 1 month. GoToSource • Use as monotherapy. GoToSource |
| Adverse Events |
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Increased risk of risk myopathy (disease of skeletal muscle) when used with statins (atorvastatin, lovastatin, simvastatin, rosuvastatin) and fibric acid derivatives. GoToSource Fatal bradyarrhythmia (slow heart rate) with lopinavir use. GoToSource Cholelithiasis (gallstones). GoToSource Increased cholesterol and triglycerides, redistribution and accumulation of body fat, hyperglycemia, insulin resistance and new-onset diabetes. GoToSource Pancreatitis (inflammation of pancreas). GoToSource Circumoral paraesthesia (abnormal skin sensation). GoToSource Avascular necrosis (death of bone tissue). GoToSource Cushing syndrome and adrenal suppression in children when used with fluticasone. GoToSource Ergotism (long-term ergot poisoning) when used with ergotamines. GoToSource Hyperbilirubinemia (too much bilirubin in blood) including jaundice. GoToSource Rash, toxic epidermal necrolysis, stevens johnson syndrome (severe skin disorder) hyperpigmentation, hair loss, hypersensitivity reactions, injection site reaction and urticarial reaction (hives). GoToSource Immune reconstitution syndrome. GoToSource Increased bleeding in patients with hemophilia. GoToSource Cross-resistance. GoToSource Seizures. GoToSource |
| Litigation |
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Lawsuits filed for abnormal heart rhythm including heart block. |
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