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Norvir
Generic Name: Ritonavir
Drug Category: HIV Protease Inhibitor
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 1 month old for a maximum duration of 144 weeks.
| Approved Uses |
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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. Because NORVIR oral solution contains ethanol and propylene glycol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility. Feeding tubes that are compatible with ethanol and propylene glycol, such as silicone and polyvinyl chloride (PVC) feeding tubes, can be used for administration of NORVIR oral solution. 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. 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. Therefore, caution should be exercised when administering NORVIR to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Increased AST/ALT monitoring should be considered in these patients, especially during the first three months of NORVIR treatment. Pancreatitis has been observed in patients receiving NORVIR therapy, including those who developed hypertriglyceridemia. In some cases fatalities have been observed. Patients with advanced HIV disease may be at increased risk of elevated triglycerides and pancreatitis. 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. 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. Ritonavir has been shown to increase triglycerides, cholesterol, SGOT (AST), SGPT (ALT), GGT, CPK, and uric acid. Appropriate laboratory testing should be performed prior to initiating NORVIR therapy and at periodic intervals or if any clinical signs or symptoms occur during therapy. 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. 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. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia, or tuberculosis), which may necessitate further evaluation and treatment. 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. 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. Cross-resistance among protease inhibitors have been observed. Dose reduction of NORVIR is necessary when used with other protease inhibitors: atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir. 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 as follows:
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:
Appropriate doses for combination with indinavir with respect to efficacy and safety, have not been Saquinavir/ritonavir in combination with rifampin is not recommended due to the risk of severe hepatotoxicity. Appropriate doses for combination with delavirdine with respect to efficacy and safety, have not been Raltegravir concentrations may be decreased with ritonavir co-administration. Avoid co-administration of encorafenib or ivosidenib with NORVIR due to potential risk of serious adverse events such as QT interval prolongation. Avoid concomitant use of rivaroxaban and ritonavir. Co-administration of ritonavir and rivaroxaban may lead to risk of increased bleeding. A dose decrease may be needed for carbamazepine, clonazepam, ethosuximide when co-administered with ritonavir and therapeutic concentration monitoring is recommended for these anticonvulsants, if available. A dose increase may be needed for divalproex, lamotrigine, phenytoin when co-administered with ritonavir and therapeutic concentration monitoring is recommended for these anticonvulsants, if available. A dose decrease may be needed for nefazodone, selective serotonin reuptake inhibitors (SSRIs): e.g. fluoxetine, paroxetine, tricyclics: e.g. amitriptyline, nortriptyline when co-administered with ritonavir. Avoid use of neratinib, venetoclax or ibrutinib with NORVIR. 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. Clinicians should be aware that if the ritonavir containing regimen is withheld for a prolonged period, consideration should be given to altering the regimen to not include a CYP3A or P-gp inhibitor in order to control HIV-1 viral load. Dosage reduction and concentration monitoring of desipramine is recommended. Adverse events of nausea, dizziness, hypotension and syncope have been observed following co-administration of trazodone and NORVIR. A lower dose of trazodone should be considered. A dose decrease of dronabinol may be needed when co-administered with ritonavir. Use with high doses of ketoconazole or itraconazole (greater than 200 mg per day) is not recommended. For patients with renal impairment, adjust clarithromycin dose as follows: For patients with CLCR 30 to 60 mL per min the dose of clarithromycin should be reduced by 50%. For patients with CLCR less than 30 mL per min the dose of clarithromycin should be decreased by 75%. Dosage reduction of rifabutin by at least three quarters of the usual dose of 300 mg per day is recommended (e.g., 150 mg every other day or three times a week). Use with rifampin may lead to loss of virologic response. Alternate antimycobacterial agents such as rifabutin should be considered. A dose decrease of quinine may be needed when co-administered with ritonavir. A dose decrease may be needed for perphenazine, risperidone, thioridazine when co-administered with ritonavir. Initiation of NORVIR in patients taking quetiapine: 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. When used with metoprolol, timolol, caution is warranted and clinical monitoring of patients is recommended. A dose decrease may be needed for these drugs when co-administered with ritonavir. Increased dosage of theophylline may be required. Concomitant administration of ritonavir with digoxin may increase digoxin levels. When used with diltiazem, nifedipine, verapamil, caution is warranted and clinical monitoring of patients is recommended. A dose decrease may be needed for these drugs when co-administered with ritonavir. Co-administration of bosentan in patients on ritonavir: In patients who have been receiving ritonavir for at least 10 days, start bosentan at 62.5 mg once daily or every other day based upon individual tolerability. Co-administration of ritonavir in patients on bosentan: 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. Concomitant use of elagolix 200 mg twice daily and NORVIR for more than 1 month is not recommended due to potential risk of adverse events such as bone loss and hepatic transaminase elevations. Limit concomitant use of elagolix 150 mg once daily and NORVIR to 6 months. It is not recommended to co-administer ritonavir with glecaprevir/pibrentasvir, or simeprevir. When used with fostamatinib, monitor for toxicities of R406 exposure resulting in dose-related adverse events such a hepatotoxicity and neutropenia. Fostamatinib dose reduction may be required. Concurrent administration of salmeterol and ritonavir is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia. Ethinyl estradiol: Alternate methods of contraception should be considered. Triazolam, orally administered midazolam are contraindicated due to potential for prolonged or increased sedation or respiratory depression. Co-administration of ADCIRCA in patients on ritonavir: In patients receiving ritonavir for at least one week, start ADCIRCA at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability. Co-administration of ritonavir in patients on ADCIRCA: 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. A dose decrease may be needed for buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem when co-administered with ritonavir. Methamphetamine: Use with caution. A dose decrease of methamphetamine may be needed when co-administered with ritonavir. Co-administration with betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, prednisone, triamcinolone whose exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression..Alternative corticosteroids including beclomethasone and prednisolone (whose PK and/or PD are less affected by strong CYP3A inhibitors relative to other studied steroids) should be considered, particularly for long-term use. 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 oral solution is not recommended during pregnancy due to its ethanol content. The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. Limited published data reports that ritonavir is present in human milk. |
| Off-label Uses |
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• Monotherapy. GoToSource • Adjunctive treatment for suspected or confirmed SARS-CoV-2 infection. GoToSource • Adjunctive treatment for middle east respiratory syndrome. GoToSource |
| Adverse Events |
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Diarrhea, hyperlipidemia (high level of fats or lipids in the blood), lipodystrophy (abnormal distribution of fat in the body), exacerbation of chronic hepatitis B or C and liver injury. GoToSource Kidney injury. GoToSource Pancreatitis (inflammation of pancreas). GoToSource Insomnia, hypertriglyceridemia (high blood triglyceride levels), transaminitis (high level of liver enzymes called transaminases), rhabdomyolysis (breakdown or destruction of muscle tissue), diabetes mellitus, hypersensitivity reactions, stevens-johnson syndrome, toxic epidermal necrolysis (severe skin disorder), leukopenia (low white blood count) and neutropenia (low level of neutrophils a type of white blood cell). GoToSource Cardiac arrhythmias. GoToSource Increased risk of bleeding. GoToSource Immune reconstitution syndrome (inflammatory reaction). GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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