Does Technivie (ombitasvir, paritaprevir and ritonavir) cause side effects?

Technivie (ombitasvir, paritaprevir and ritonavir) is a fixed-dose combination of antiviral medicines including a hepatitis C virus NS5A inhibitor, a hepatitis C virus NS3/4A protease inhibitor, and a CYP3A inhibitor, used with ribavirin to treat adults with genotype 4 chronic (lasting a long time) hepatitis C virus (HCV) infection without cirrhosis or with a certain type of cirrhosis (compensated). Patients should also read the Medication Guide for ribavirin. 

Common side effects of Technivie include:

Serious side effects of Technivie include:

Drug interactions of Technivie include alfuzosin hydrochloride, atorvastatin, carbamazepine, cisapride, colchicine in people who have:

If Technivie is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on use in pregnancy.

It is unknown if Technivie and its metabolites are present in human breast milk, if it affects human milk production, or will have effects on a breastfed infant.  The developmental and heal

What are the important side effects of Technivie (ombitasvir, paritaprevir and ritonavir)?

WARNING

  • Hepatitis B virus reactivation: Before starting treatment with Technivie, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment for hepatitis C virus with Technivie. Hepatitis B virus that becomes active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking Technivie.
  • Severe liver problems, especially in people with certain types of cirrhosis. These severe liver problems can lead to the need for a liver transplant, or can lead to death. If you have cirrhosis, your healthcare provider will check your liver before and during treatment with Technivie.
  • Increases in your liver function blood tests, especially if you use ethinyl estradiol-containing medicines (contained in certain birth control products).
  • You must stop using ethinyl estradiol-containing medicines before you start treatment with Technivie. See the prescribing information for a list of these medicines.
    • If you use these medicines as a method of birth control, you must use another method of birth control during treatment with Technivie, and for about 2 weeks after you finish treatment with Technivie. Your healthcare provider will tell you when you may begin taking ethinyl estradiolcontaining medicines.
  • Your healthcare provider should do blood tests to check your liver function during the first 4 weeks and then as needed, during treatment with Technivie.
  • Your healthcare provider may tell you to stop taking Technivie if you develop signs or symptoms of liver problems.

Tell your healthcare provider right away if you develop any of the following symptoms, or if they worsen during treatment with Technivie:

  • tiredness
  • weakness
  • loss of appetite
  • nausea and vomiting
  • yellowing of your skin or eyes
  • color changes in your stools
  • confusion
  • swelling of the stomach area

Common side effects of Technivie when used with ribavirin include:

These are not all the possible side effects of Technivie. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Technivie (ombitasvir, paritaprevir and ritonavir) side effects list for healthcare professionals

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:

  • Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis 
  • Increased Risk of ALT Elevations 

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of ombitasvir, paritaprevir and ritonavir cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reaction In Subjects Without Cirrhosis

The safety assessment of Technivie is based on data from two clinical studies in subjects with HCV genotype 4 infection. PEARL-I was a study including 135 subjects without cirrhosis, 91 who received ombitasvir 25 mg, paritaprevir 150 mg and ritonavir 100 mg (administered as one ombitasvir 25 mg tablet, three paritaprevir 50 mg tablets and one ritonavir 100 mg capsule) once daily with ribavirin for 12 weeks and 44 subjects who received ombitasvir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg (administered as one ombitasvir 25 mg tablet, three paritaprevir 50 mg tablets and one ritonavir 100 mg capsule) once daily without ribavirin for 12 weeks.

Adverse reactions that occurred in subjects without cirrhosis treated with ombitasvir, paritaprevir and ritonavir with or without ribavirin for 12 weeks are listed in Table 2. The majority of adverse reactions in non-cirrhotic subjects were mild in severity, none were serious and none led to discontinuation of treatment.

Table 2. Selected Adverse Reactions (All Grades) with ≥5% Frequency Reported in Subjects with HCV Genotype 4 Infection without Cirrhosis Treated with Ombitasvir, Paritaprevir and Ritonavir with or without Ribavirin for 12 Weeks

Adverse ReactionPEARL-I Without Cirrhosis
Ombitasvir, paritaprevir, ritonavir + RBV
N = 91
%
Ombitasvir, paritaprevir, ritonavir
N = 44
%
Asthenia2925
Fatigue157
Nausea149
Insomnia135
Pruritus175
Skin reactions2,375
1Grouped term ‘pruritus’ includes the preferred terms pruritus and pruritus generalized.
2Grouped term ‘skin reactions’ includes the preferred terms rash, erythema, eczema, rash maculo-papular, rash macular, dermatitis, rash papular, skin exfoliation, rash pruritic, rash erythematous, rash generalized, dermatitis allergic, dermatitis contact, exfoliative rash, photosensitivity reaction, psoriasis, skin reaction, ulcer and urticaria.
3The majority of events were graded as mild in severity.

Adverse Events In Subjects With Compensated Cirrhosis

AGATE-I was a study including 120 subjects with compensated cirrhosis who received Technivie once daily with ribavirin for a total of 12 weeks (n=60) or 16 weeks (n=60). Adverse events occurring up to and including 12 weeks of treatment (≤ 84 days) from both arms were included in the analysis of adverse events and are listed in Table 3.

Seven of 120 subjects (6%) experienced serious adverse events at or before 12 weeks of treatment. No adverse events led to the discontinuation of Technivie. Thirty-one subjects (26%) underwent ribavirin dose reductions; five discontinued ribavirin, three received transfusion and one received erythropoietin.

Table 3. Selected Adverse Events (All Grades) with ≥5% Frequency Reported in Subjects with HCV Genotype 4 Infection with Compensated Cirrhosis Treated with Technivie and Ribavirin through 12 Weeks

Adverse EventsAGATE-I Compensated Cirrhosis
Technivie + RBV
N=120
(%)
Fatigue25
Asthenia25
Headache23
Musculoskeletal Pain/Changes117
Pruritus16
Insomnia/Sleep Disorder214
Skin Reactions313
Dyspnea411
Mood Disorders511
Nausea11
Dizziness11
Cardiac Events69
Abdominal Pain79
Cough7
Clinical Liver or Bilirubin Related Events87
Edema96
Altered Mental Status106
Decreased Appetite6
Vomiting6
1Grouped term ‘musculoskeletal pain/changes’ includes the preferred terms arthralgia, arthritis, back pain, muscle injury, muscle spasms, muscular weakness, musculoskeletal chest pain, myalgia, neck pain, and pain in extremity.
2Grouped term ‘insomnia/sleep disorder’ includes preferred terms insomnia and sleep disorder.
3Grouped term ‘skin reactions’ includes preferred terms dermatitis bullous, dermatitis psoriasiform, dry skin, eczema asteatotic, erythema, rash, skin exfoliation, skin lesion and skin toxicity.
4Grouped term ‘dyspnea’ includes preferred terms dyspnea and dyspnea exertional.
5Grouped term ‘mood disorders’ includes preferred terms affective disorder, agitation, anxiety, depressed mood, depression, irritability, mania and suicide attempt.
6Grouped term ‘cardiac events’ includes preferred terms acute coronary syndrome, angina pectoris, atrial fibrillation, chest pain, hypertension, hypotension and palpitations.
7Grouped term ‘abdominal pain’ includes preferred terms abdominal discomfort, abdominal pain, abdominal pain lower and abdominal pain upper.
8Grouped term ‘clinical liver or bilirubin related events’ includes preferred terms ascites, hepatic encephalopathy, jaundice, ocular icterus, esophageal varices hemorrhage and portal vein thrombosis.
9Grouped term ‘edema’ includes preferred terms edema and edema peripheral.
10Grouped term ‘altered mental status’ includes preferred terms disturbance in attention, memory impairment, psychomotor retardation and somnolence.

Laboratory Abnormalities

Serum ALT Elevations

None of the 135 subjects without cirrhosis and two (2%) of the 120 subjects with compensated cirrhosis treated with Technivie experienced post-baseline serum ALT levels greater than 5 times the upper limit of normal (ULN) and ≥2 times baseline after starting treatment [see WARNINGS AND PRECAUTIONS].

Serum Bilirubin Elevations in Patients without Cirrhosis

Post-baseline elevations in bilirubin at least 2 times ULN were observed in 5% (7/134) of subjects without cirrhosis, receiving Technivie, all of whom were also receiving RBV. These bilirubin increases were predominately indirect and related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and possibly ribavirin-induced hemolysis. Bilirubin elevations occurred early after initiation of treatment, peaked by study Week 1, and generally resolved with ongoing therapy. Bilirubin elevations were generally not associated with serum ALT elevations.

Serum Bilirubin Elevations/Hepatic Decompensation in Patients with Compensated Cirrhosis

Among the 120 subjects with compensated cirrhosis, mean total bilirubin and mean indirect bilirubin levels increased to approximately 3 fold from baseline on treatment. Mean direct bilirubin levels increased to approximately 2 fold on treatment. Mean bilirubin elevations occurred early, peaked by Week 1, remained elevated on treatment and normalized by post treatment week 4. Bilirubin elevations were generally not associated with serum ALT elevations.

Over 40% (50/120) of subjects across both arms experienced elevated direct bilirubin levels (>ULN) at or before 12 weeks of treatment. Twelve percent (6/50) of these subjects experienced clinical bilirubin or liver related events including jaundice, ocular icterus and portal vein thrombosis.

One subject who did not have direct bilirubin elevations also experienced liver related adverse events of esophageal varices and ascites.

Anemia/Decreased Hemoglobin in Patients without Cirrhosis

The mean change from baseline in hemoglobin levels in subjects without cirrhosis treated with Technivie in combination with ribavirin was -2.1 g/dL and the mean change in subjects treated with Technivie alone was -0.4 g/dL. Decreases in hemoglobin levels occurred early in treatment (Week 1-2) with further reductions through Week 3. Hemoglobin values remained low during the remainder of treatment and returned towards baseline levels by post-treatment Week 4.

One subject treated with Technivie with ribavirin had a single hemoglobin level decrease to less than 8 g/dL during treatment. No subject treated with Technivie alone had hemoglobin levels less than 8 g/dL. Four percent (4/91) of subjects without cirrhosis treated with Technivie with ribavirin underwent ribavirin dose reductions to manage anemia/decreased hemoglobin levels. No subject received erythropoietin.

Anemia/Decreased Hemoglobin in Patients with Compensated Cirrhosis

Across both treatment arms, 4/120 cirrhotic subjects (3%) had anemia (hemoglobin less than LLN) prior to initiation of treatment. However, 88/120 (73%) had anemia (hemoglobin less than LLN) and/or a hemoglobin decrease of ≥ 2g/dl at or before 12 weeks of treatment. One subject (1%) had a single hemoglobin value less than 8.0 g/dL on treatment at or before 12 weeks of treatment. Reductions in hemoglobin are most likely primarily related to ribavirin in this population.

Of 64 subjects with a history of cardiovascular disease or diabetes mellitus, 9 (14%) experienced cardiac adverse events at or before 12 weeks of treatment. These 9 subjects had a mean hemoglobin decrease of 3.9 g/dL (range 1.1 to 5.3 g/dL) from baseline and experienced cardiac events including acute coronary syndrome, angina pectoris, chest pain, atrial fibrillation, palpitations, hypotension and hypertension. Among 56 subjects without a prior history of cardiovascular disease or diabetes, 2 (4%) experienced a cardiac event (mild or moderate hypertension).

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of Technivie. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Anaphylactic reactions and other hypersensitivity reactions (including angioedema).

Hepatobiliary Disorders: Hepatic decompensation, hepatic failure.

Skin and Subcutaneous Tissue Disorders: Erythema multiforme (EM).

What drugs interact with Technivie (ombitasvir, paritaprevir and ritonavir)?

Potential For Technivie To Affect Other Drugs

Paritaprevir is an inhibitor of OATP1B1 and OATP1B3 and paritaprevir and ritonavir are inhibitors of BCRP and P-gp. Ritonavir is an inhibitor of CYP3A4. Co-administration of Technivie with drugs that are substrates of CYP3A, P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased plasma concentrations of such drugs.

Potential For Other Drugs To Affect One Or More Components Of Technivie

Paritaprevir and ritonavir are primarily metabolized by CYP3A enzymes. Co-administration of Technivie with strong inhibitors of CYP3A may increase paritaprevir and ritonavir concentrations. Ombitasvir is primarily metabolized via amide hydrolysis while CYP enzymes play a minor role in its metabolism. Ombitasvir, paritaprevir and ritonavir are substrates of P-gp. Paritaprevir is a substrate of BCRP, OATP1B1 and OATP1B3. Inhibition of P-gp, BCRP, OATP1B1 or OATP1B3 may increase the plasma concentrations of the various components of Technivie.

Established And Other Potential Drug Interactions

Clearance of HCV infection with direct-acting antivirals may lead to changes in hepatic function, which may impact the safe and effective use of concomitant medications. For example, altered blood glucose control resulting in serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies. Management of hypoglycemia in these cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment.

Frequent monitoring of relevant laboratory parameters (e.g. International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of concomitant medications such as CYP P450 substrates with a narrow therapeutic index (e.g. certain immunosuppressants) is recommended to ensure safe and effective use. Dose adjustments of concomitant medications may be necessary.

If dosage adjustments of concomitant medications are made due to treatment with Technivie, dosages should be re-adjusted after administration of Technivie is completed. Dosage adjustment is not required for Technivie.

Table 4 provides the effect of co-administration of Technivie on concentrations of concomitant drugs and the effect of concomitant drugs on the various components of Technivie. Refer to the ritonavir prescribing information for other potentially significant drug interactions with ritonavir.

Table 4. Drug Interactions

Concomitant Drug
Class: Drug Name
Effect on ConcentrationClinical Comments
ALPHA1-ADRENORECEPTOR ANTAGONIST
alfuzosin HCl*↑ alfuzosin HClContraindicated due to potential for hypotension.
ANDROGEN RECEPTOR INHIBITOR
apalutamide*↓ ombitasvir
↓ paritaprevir
↓ ritonavir
Contraindicated due to potential loss of therapeutic activity of Technivie.
ANGIOTENSIN RECEPTOR BLOCKERS e.g.
valsartan*,
losartan*,
candesartan*
↑ angiotensin receptor blockersDecrease the dose of the angiotensin receptor blockers and monitor patients for signs and symptoms of hypotension and/or worsening renal function. If such events occur, consider further dose reduction of the angiotensin receptor blocker or switching to an alternative to the angiotensin receptor blocker.
ANTI-ANGINAL
ranolazine*↑ ranolazineContraindicated due to potential for serious and/or life-threatening reactions.
ANTIARRHYTHMICS
dronedarone*↑ dronedaroneContraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
digoxin↑ digoxinFor contraindicated antiarrhythmics.
Decrease digoxin dose by 30-50%. Appropriate monitoring of serum digoxin levels is recommended.
amiodarone*,
bepridil*,
disopyramide*,
flecainide*,
lidocaine (systemic)*,
mexiletine*,
propafenone*,
quinidine*
↑ antiarrhythmicsTherapeutic monitoring (if available) is recommended for antiarrhythmics when co-administered with Technivie.
ANTICANCER AGENTS/KINASE INHIBITORS
encorafenib*
fostamatinib*
ibrutinib*
ivosidenib*
↑ anticancer agents/kinase inhibitorsCo-administration of Technivie with these anticancer agents/kinase inhibitors may result in increased risk for adverse events. Refer to the prescribing information of these agents for details on co-administration with strong CYP3A inhibitors.
ANTICONVULSANTS
carbamazepine*,
phenytoin*,
phenobarbital*
↓ ombitasvir
↓ paritaprevir
↓ ritonavir
Contraindicated due to potential loss of therapeutic activity of Technivie.
ANTIDIABETIC DRUGS
metformin↔ metforminMonitor for signs of onset of lactic acidosis such as respiratory distress, somnolence, and nonspecific abdominal distress or worsening renal function. Concomitant metformin use in patients with renal insufficiency or hepatic impairment is not recommended. Refer to the prescribing information of metformin for further guidance.
ANTI-GOUT
colchicine*↑ colchicineContraindicated due to potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment.
ANTIFUNGALS
ketoconazole↑ ketoconazoleWhen Technivie is co-administered with ketoconazole, the maximum daily dose of ketoconazole should be limited to 200 mg per day.
voriconazole*↓ voriconazoleCo-administration of Technivie with voriconazole is not recommended unless an assessment of the benefit-to-risk ratio justifies the use of voriconazole.
ANTIMYCOBACTERIAL
rifampin*↓ ombitasvir
↓ paritaprevir
↓ ritonavir
Contraindicated due to potential loss of therapeutic activity of Technivie.
ANTIPSYCHOTICS
lurasidone*↑ lurasidoneContraindicated due to potential for serious and/or life-threatening reactions.
pimozide*↑ pimozideContraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
quetiapine*↑ quetiapineFor contraindicated antipsychotics.
  • Initiation of Technivie in patients taking quetiapine: Consider alternative anti-HCV therapy to avoid increases in quetiapine exposures. If coadministration is necessary, reduce the quetiapine dose to 1/6th of the current dose and monitor for quetiapineassociated adverse reactions. Refer to the quetiapine prescribing information for recommendations on adverse reaction monitoring.
  • Initiation of quetiapine in patients taking Technivie: Refer to the quetiapine prescribing information for initial dosing and titration of quetiapine.
CALCIUM CHANNEL BLOCKERS
amlodipine,
nifedipine*,
diltiazem*,
verapamil*
↑ calcium channel blockersDecrease the dose of the calcium channel blocker. The dose of amlodipine should be decreased by at least 50%. Clinical monitoring of patients is recommended for edema and/or signs and symptoms of hypotension. If such events occur, consider further dose reduction of the calcium channel blocker or switching to an alternative to the calcium channel blocker.
CORTICOSTEROIDS (INHALED/NASAL)
fluticasone*↑ fluticasoneConcomitant use of Technivie with inhaled or nasal fluticasone may reduce serum cortisol concentrations. Alternative corticosteroids should be considered, particularly for long term use.
DIURETICS
furosemide↑ furosemide (Cmax)Clinical monitoring of patients is recommended and therapy should be individualized based on patient’s response.
ERGOT DERIVATIVES
ergotamine*,
dihydroergotamine*,
methylergonovine*
↑ ergot derivativesContraindicated due to potential for acute ergot toxicity characterized by vasospasm. Tissue ischemia has been associated with co-administration of ritonavir and ergonovine, ergotamine, dihydroergotamine, or methylergonovine.
ETHINYL ESTRADIOL-CONTAINING PRODUCTS
ethinyl estradiolcontaining medications such as combined oral contraceptives↔ ethinyl estradiolContraindicated due to potential for ALT elevations.
GI MOTILITY AGENT
cisapride*↑ cisaprideContraindicated due to potential for serious and/or life threatening reactions such as cardiac arrhythmias.
GnRH RECEPTOR ANTAGONISTS
elagolix*↑ elagolixCo-administration of Technivie with elagolix 200 mg twice daily for more than 1 month is not recommended.
HERBAL PRODUCT
St. John’s Wort*
(Hypericum perforatum)
↓ ombitasvir
↓ paritaprevir
↓ ritonavir
Contraindicated due to potential loss of therapeutic activity of Technivie.
HIV-ANTIVIRAL AGENTS
efavirenz*↑ efavirenz
↓ paritaprevir
↓ ritonavir
Contraindicated as co-administration of efavirenz based regimens with paritaprevir and ritonavir was poorly tolerated and resulted in liver enzyme elevations.
atazanavir or atazanavir/ritonavir↑ paritaprevirCo-administration of Technivie with atazanavir or atazanavir/ritonavir is not recommended.
darunavir/ritonavir↓ darunavir (Ctrough)Treatment naïve patients or treatment experienced patients with no darunavir-associated mutations:
Darunavir 800 mg once daily (without ritonavir) can be co-administered with Technivie.
lopinavir/ritonavir↑ paritaprevirCo-administration of Technivie with lopinavir/ritonavir is not recommended.
rilpivirine↑ rilpivirineFor contraindicated non-nucleoside reverse transcriptase inhibitors.
Co-administration of Technivie with rilpivirine once daily is not recommended due to potential for QT interval prolongation with higher concentrations of rilpivirine.
HMG CoA REDUCTASE INHIBITORS
atorvastatin
lovastatin,
simvastatin
↑ atorvastatin
↑ lovastatin,
↑ simvastatin
Contraindicated due to potential for myopathy including rhabdomyolysis.
pravastatin↑ pravastatinFor contraindicated HMG CoA Reductase Inhibitors.
When Technivie is co-administered with pravastatin, the dose of pravastatin should not exceed 40 mg per day.
IMMUNOSUPPRESSANTS
everolimus sirolimus tacrolimus↑ everolimus
↑ sirolimus
↑ tacrolimus
Contraindicated due to potential for serious and/or life threatening immunosuppressant-associated adverse events.
cyclosporine↑ cyclosporineFor contraindicated immunosuppressants.
When initiating therapy with Technivie, reduce cyclosporine dose to 1/5th of the patient’s current cyclosporine dose. Measure cyclosporine blood concentrations to determine subsequent dose modifications. Upon completion of Technivie therapy, the appropriate time to resume pre-Technivie dose of cyclosporine should be guided by assessment of cyclosporine blood concentrations. Frequent assessment of renal function and cyclosporine-related side effects is recommended.
LONG ACTING BETA-ADRENOCEPTOR AGONIST
salmeterol*↑ salmeterolConcurrent administration of Technivie and salmeterol is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
MUSCLE RELAXANTS
carisoprodol↓ carisoprodol
↔ mepobramate (metabolite of carisoprodol)
Increase dose if clinically indicated.
cyclobenzaprine↓cyclobenzaprine
↓norcyclobenzaprine (metabolite of cyclobenzaprine)
Increase dose if clinically indicated.
MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN INHIBITOR
lomitapide*↑ lomitapideContraindicated due to potential for serious adverse events including hepatotoxicity.
NARCOTIC ANALGESICS
buprenorphine/naloxone↑ buprenorphine
↑ norbuprenorphine (metabolite of buprenorphine)
Patients should be closely monitored for sedation and cognitive effects.
hydrocodone/ acetaminophen↑ hydrocodone
↔ acetaminophen
Reduce the dose of hydrocodone by 50% and monitor patients for respiratory depression and sedation at frequent intervals. Upon completion of Technivie therapy, adjust the hydrocodone dose and monitor for signs of opioid withdrawal.
fentanyl↑ fentanylCareful monitoring of therapeutic effects and adverse effects of fentanyl (including potentially fatal respiratory depression) is recommended when fentanyl is co-administered with Technivie.
PROTON PUMP INHIBITORS
omeprazole↓ omeprazoleMonitor patients for decreased efficacy of omeprazole. Consider increasing the omeprazole dose in patients whose symptoms are not well controlled; avoid use of more than 40 mg per day of omeprazole.
PHOSPHODIESTERASE-5 (PDE5) INHIBITOR
Sildenafil* when dosed as Revatio for the treatment of pulmonary arterial hypertension (PAH)↑ sildenafilContraindicated due to potential for sildenafilassociated adverse events such as visual disturbances, hypotension, priapism, and syncope.
SEDATIVES/HYPNOTICS
triazolam* orally administered midazolam*↑ triazolam
↑ midazolam
Contraindicated due to potential for serious and/or life threatening events such as prolonged or increased sedation or respiratory depression.
alprazolam↑ alprazolamFor contraindicated Sedatives/Hypnotics.
Clinical monitoring of patients is recommended. A decrease in alprazolam dose can be considered based on clinical response.
diazepam↓ diazepam
↓ nordiazepam (metabolite of diazepam)
Increase dose if clinically indicated.
*Not studied.
See CLINICAL PHARMACOLOGY, Tables 7 and 8.
The direction of the arrow indicates the direction of the change in exposures (Cmax and AUC) (↑ = increase of more than 20%, ↓ = decrease of more than 20%).

Drugs Without Clinically Significant Interactions With Technivie

No dosage adjustments are recommended when Technivie is co-administered with the following medications:

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Technivie and any potential adverse effects on the breastfed child from Technivie or from the underlying maternal condition. If Technivie is administered with ribavirin, the nursing information for ribavirin also applies to this combination regimen.

Summary

Technivie (ombitasvir, paritaprevir and ritonavir) is a fixed-dose combination of antiviral medicines including a hepatitis C virus NS5A inhibitor, a hepatitis C virus NS3/4A protease inhibitor, and a CYP3A inhibitor, used with ribavirin to treat adults with genotype 4 chronic (lasting a long time) hepatitis C virus (HCV) infection without cirrhosis or with a certain type of cirrhosis (compensated). Common side effects of Technivie include feeling weak, tiredness, headache, changes in mood, itching, nausea, sleep problems, trouble breathing, muscle or joint pain, skin reactions, and dizziness. Technivie is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. It is unknown if Technivie and its metabolites are present in human breast milk, if it affects human milk production, or will have effects on a breastfed infant.

Treatment & Diagnosis

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Medically Reviewed on 5/19/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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