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Overview
What is Technivie?
TECHNIVIE is a fixed-dose combination tablet containing ombitasvir, paritaprevir, and ritonavir for oral administration.
Ombitasvir, paritaprevir, ritonavir fixed dose combination tablet includes a hepatitis C virus NS5A inhibitor (ombitasvir), a hepatitis C virus NS3/4A protease inhibitor (paritaprevir), and a CYP3A inhibitor (ritonavir) that inhibits CYP3A mediated metabolism of paritaprevir, thereby providing increased plasma concentration of paritaprevir.
Ombitasvir
The chemical name of ombitasvir is Dimethyl ([(2,5)-1-(4--butylphenyl) pyrrolidine-2,5-diyl]bis{benzene-4,1-diylcarbamoyl(2)pyrrolidine-2,1-diyl[(2)-3-methyl-1-oxobutane-1,2-diyl]})biscarbamate hydrate. The molecular formula is CHNO•4.5HO (hydrate) and the molecular weight for the drug substance is 975.20 (hydrate). The drug substance is white to light yellow to light pink powder, and is practically insoluble in aqueous buffers but is soluble in ethanol. Ombitasvir has the following molecular structure:
Paritaprevir
The chemical name of paritaprevir is (2R,6S,12Z,13aS,14aR,16aS)-N-(cyclopropylsulfonyl)-6-{[(5-methylpyrazin-2-yl)carbonyl]amino}-5,16-dioxo-2-(phenanthridin-6-yloxy)-1,2,3,6,7,8,9,10,11,13a,14,15,16,16a-tetradecahydrocyclopropa[]pyrrolo[1,2-][1,4] diazacyclopentadecine-14a(5H)-carboxamide dihydrate. The molecular formula is CHNOS•2HO (dihydrate) and the molecular weight for the drug substance is 801.91 (dihydrate). The drug substance is white to off-white powder with very low water solubility. Paritaprevir has the following molecular structure:
Ritonavir
The chemical name of ritonavir is [5S-(5R*,8R*,10R*,11R*)]10-Hydroxy-2-methyl-5-(1-methyethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid,5-thiazolylmethyl ester. The molecular formula is CHNOS and the molecular weight for the drug substance is 720.95. The drug substance is white to off white to light tan powder practically insoluble in water and freely soluble in methanol and ethanol. Ritonavir has the following molecular structure:
Ombitasvir, Paritaprevir, Ritonavir Fixed-Dose Combination Tablets
Ombitasvir, paritaprevir and ritonavir film-coated tablets are co-formulated immediate release tablets. The tablet contains copovidone, K value 28, vitamin E polyethylene glycol succinate, propylene glycol monolaurate Type I, sorbitan monolaurate, colloidal silicon dioxide/colloidal anhydrous silica, sodium stearyl fumarate, polyvinyl alcohol, polyethylene glycol 3350/macrogol 3350, talc, titanium dioxide, and iron oxide red. The strength for the tablet is 12.5 mg ombitasvir, 75 mg paritaprevir, 50 mg ritonavir.
What does Technivie look like?
What are the available doses of Technivie?
Tablets: 12.5 mg ombitasvir, 75 mg paritaprevir, 50 mg ritonavir. ()
What should I talk to my health care provider before I take Technivie?
How should I use Technivie?
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TECHNIVIE is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis
[see Clinical Studies ()]
Test all patients for HBV infection by measuring HBsAg and anti-HBc. ()
Assess hepatic laboratory and clinical evidence of hepatic decompensation. Prior to initiation of ribavirin, assess for underlying cardiac disease. ()
Recommended dosage: Two tablets taken orally once daily (in the morning) with a meal without regard to fat or calorie content. TECHNIVIE is recommended to be used in combination with ribavirin. ()
What interacts with Technivie?
Sorry No Records found
What are the warnings of Technivie?
Sorry No Records found
What are the precautions of Technivie?
Sorry No Records found
What are the side effects of Technivie?
Sorry No records found
What should I look out for while using Technivie?
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Table 2
[see Drug Interactions ()]
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Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with TECHNIVIE. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated
What might happen if I take too much Technivie?
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
How should I store and handle Technivie?
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. TECHNIVIE is dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs. Each child resistant daily dose pack contains two TECHNIVIE tablets. The NDC number is 0074-3082-28.TECHNIVIE is a pink-colored, film-coated, oblong, biconvex-shaped tablet debossed with “AV1” on one side. Each tablet contains 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.Store at or below 30°C (86°F).TECHNIVIE is dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs. Each child resistant daily dose pack contains two TECHNIVIE tablets. The NDC number is 0074-3082-28.TECHNIVIE is a pink-colored, film-coated, oblong, biconvex-shaped tablet debossed with “AV1” on one side. Each tablet contains 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.Store at or below 30°C (86°F).TECHNIVIE is dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs. Each child resistant daily dose pack contains two TECHNIVIE tablets. The NDC number is 0074-3082-28.TECHNIVIE is a pink-colored, film-coated, oblong, biconvex-shaped tablet debossed with “AV1” on one side. Each tablet contains 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.Store at or below 30°C (86°F).TECHNIVIE is dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs. Each child resistant daily dose pack contains two TECHNIVIE tablets. The NDC number is 0074-3082-28.TECHNIVIE is a pink-colored, film-coated, oblong, biconvex-shaped tablet debossed with “AV1” on one side. Each tablet contains 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.Store at or below 30°C (86°F).
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Clinical Information
Chemical Structure
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Clinical Pharmacology
TECHNIVIE combines two direct-acting hepatitis C virus antiviral agents with distinct mechanisms of action .
Ritonavir is not active against HCV. Ritonavir is a potent CYP3A inhibitor that increases peak and trough plasma drug concentrations of paritaprevir and overall drug exposure (i.e., area under the curve).
Non-Clinical Toxicology
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Table 2
[see Drug Interactions ()]
p5366291487199104
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with TECHNIVIE. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated
Inhibitors of CYP3A4 and CYP2D6
The concomitant use of PRIMLEV™ and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of PRIMLEV™ and CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of PRIMLEV™ is achieved [see
].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see
], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to PRIMLEV™.
If concomitant use is necessary, consider dosage reduction of PRIMLEV™ until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the PRIMLEV™ dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
Inducers of CYP3A4
The concomitant use of PRIMLEV™ and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of oxycodone [see
], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to PRIMLEV™ [see
].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see
], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use is necessary, consider increasing the PRIMLEV™ dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider PRIMLEV™ dosage reduction and monitor for signs of respiratory depression.
Benzodiazepines and Other CNS Depressants
Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants such as benzodiazepines and other sedative hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see
].
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tryptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see
].
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue PRIMLEV™ if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, linezolid, may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see
].
The use of PRIMLEV™ is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of PRIMLEV™ and/or precipitate withdrawal symptoms.
Advise patient to avoid concomitant use of these drugs.
Muscle Relaxants
PRIMLEV™ may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.
If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of PRIMLEV™ and/or the muscle relaxant as necessary.
Diuretics
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when PRIMLEV™ is used concomitantly with anticholinergic drugs.
Alcohol, ethyl
Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.
Oral Contraceptives
Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.
Charcoal (activated)
Reduces acetaminophen absorption when administered as soon as possible after overdose.
Beta Blockers (Propranolol)
Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased.
Loop Diuretics
The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.
Lamotrigine
Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.
Probenecid
Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.
Zidovudine
The pharmacologic effects of zidovudine may be decreased because of enhanced non-hepatic or renal clearance of zidovudine.
Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive). HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients
HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.
Test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before initiating HCV treatment with TECHNIVIE. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with TECHNIVIE and during post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
TECHNIVIE should be administered with ribavirin (RBV). Refer to the prescribing information for ribavirin for a list of ribavirin-associated adverse reactions.
The following adverse reaction is described below and elsewhere in the labeling:
