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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
TECHNIVIE (NDA-207931)
(OMBITASVIR; PARITAPREVIR; RITONAVIR)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
12/06/2019 (SUPPL-13)
4 Contraindications
(additions underlined)
…
With drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events :
…
Microsomal triglyceride transfer protein inhibitor: lomitapide
With drugs that are moderate or strong inducers of CYP3A and strong inducers of CYP2C8 and may lead to reduced efficacy of VIEKIRA XR:
Androgen receptor inhibitor: apalutamide
…
7 Drug Interactions
7.3 Established and Other Potential Drug Interactions(additions underlined)
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.
…
Table 4. Drug Interactions
(addition of the following to Table 4, please refer to label for more information)
ANTICANCER AGENTS/KINASE INHIBITORS
encorafenib
fostamatinib
ibrutinib
ivosidenib
GnRH RECEPTOR ANTAGONISTS
elagolix
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE(additions underlined)
…
Do not take TECHNIVIE if you:
- have moderate to severe liver problems
- take any of the following medicines:
…
apalutamide
...
lomitapide
…
07/23/2018 (SUPPL-12)
6 Adverse Reactions
6.2 Post-Marketing Experience(addition underlined)
…
Immune System Disorders: Anaphylactic reactions and other hypersensitivity reactions (including angioedema).
…
7 Drug Interactions
7.3 Established and Other Potential Drug Interactions(Table 5 updated to include information regarding Fentanyl)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION(additions underlined)
…
Pregnancy
Advise patients that extreme care must be taken to avoid pregnancy during treatment with TECHNIVIE with ribavirin and within 6 months of stopping ribavirin in both female patients and in female partners of male patients. Inform patients to notify their health care provider immediately in the event of a pregnancy.
…
Administration
…
Advise patients not to remove tablets from the daily dose pack until they are ready to take them.
…
11/09/2017 (SUPPL-11)
6 Adverse Reactions
6.2 Post-Marketing Adverse Reactions(additions underlined)
…
Skin and Subcutaneous Tissue Disorders: Erythema multiforme (EM)
7 Drug Interactions
7.1 Potential for TECHNIVIE to Affect Other Drugs(additions underlined)
…
Fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment, including treatment with TECHNIVIE. If TECHNIVIE is coadministered with warfarin, close monitoring of INR values is recommended during treatment and post-treatment follow-up.
03/22/2017 (SUPPL-7)
4 Contraindications
Table 2. Drugs that are Contraindicated with TECHNIVIE Drug(s) within Class (Table has been revised; please refer to label)
7 Drug Interactions
7.3 Established and Other Potential Drug InteractionsTable 5. Established Drug Interactions Based on Drug Interaction Trials (Table has been revised; please refer to label)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE(Additions and/or revisions are underlined)
Who should not take TECHNIVIE?
Do not take TECHNIVIE if you:
take any of the following medicines:
atorvastatin (Caduet, Lipitor, Liptruzet)
colchicine (Colcrys) in patients who have certain kidney or liver problems
everolimus (Afinitor, Zortress)
sirolimus (Rapamune)
tacrolimus (Astagraf XL, Envarsus XR, Prograf)
03/22/2017 (SUPPL-9)
4 Contraindications
Table 2. Drugs that are Contraindicated with TECHNIVIE Drug(s) within Class (Table has been revised; please refer to label)
7 Drug Interactions
7.3 Established and Other Potential Drug InteractionsTable 5. Established Drug Interactions Based on Drug Interaction Trials (Table has been revised; please refer to label)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE(Additions and/or revisions are underlined)
Who should not take TECHNIVIE?
Do not take TECHNIVIE if you:
take any of the following medicines:
atorvastatin (Caduet, Lipitor, Liptruzet)
colchicine (Colcrys) in patients who have certain kidney or liver problems
everolimus (Afinitor, Zortress)
sirolimus (Rapamune)
tacrolimus (Astagraf XL, Envarsus XR, Prograf)
02/24/2017 (SUPPL-6)
5 Warnings and Precautions
5.2 Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis(Additions and/or revisions are underlined)
Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported in clinical trials and postmarketing in patients treated with ombitasvir, paritaprevir, ritonavir with and without ribavirin.
For patients with compensated cirrhosis:
Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal hemorrhage).
Hepatic laboratory testing including direct bilirubin levels should be performed at baseline and during the first 4 weeks of starting treatment and as clinically indicated.
Discontinue TECHNIVIE in patients who develop evidence of hepatic decompensation.
(Additions and/or revisions are underlined)
The warnings and precautions for ribavirin, in particular the pregnancy avoidance warning and use in patients with cardiac disease, apply to this combination regimen…
(Additions and/or revisions are underlined)
See Table 5 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations…
6 Adverse Reactions
6.1 Clinical Trials Experience(Additions and/or revisions are underlined)
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…
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 3. The majority of adverse reactions in non-cirrhotic subjects were mild in severity, none were serious and none led to discontinuation of treatment.
Table 3. Selected Adverse Reactions (All Grades) with Greater than or Equal to 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 (Table has been revised; please refer to label)
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 (less than or equal to 84 days) from both arms were included in the analysis of adverse events and are listed in Table 4.
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 4. Selected Adverse Events (All Grades) with Greater than or Equal to 5% Frequency Reported in Subjects with HCV Genotype 4 Infection with Compensated Cirrhosis Treated with TECHNIVIE and Ribavirin through 12 Weeks (Table has been added; please refer to label)
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 greater than or equal to 2 times baseline after starting treatment.
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…
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 … 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 greater than or equal to 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).
7 Drug Interactions
7.3 Established and Other Potential Drug Interactions(Additions and/or revisions are underlined)
Table 5 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.
Table 5. Established Drug Interactions Based on Drug Interaction Trials
8 Use in Specific Populations
8.1 Pregnancy(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
Risk Summary
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.
No adequate human data are available to establish whether or not TECHNIVIE poses a risk to pregnancy outcomes. In animal reproduction studies, no adverse developmental effects were observed when the components of TECHNIVIE were administered separately during organogenesis and lactation. During organogenesis, the exposures were up to 29 and 4 times (mice and rabbits, respectively; ombitasvir), 12 and 143 times (mice and rats, respectively; paritaprevir, ritonavir) exposures at the recommended clinical dose of TECHNIVIE. In rodent pre/postnatal developmental studies, maternal systemic exposures (AUC) to ombitasvir and paritaprevir were approximately 26 and 24 times, respectively, the exposure in humans at the recommended clinical dose.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal data
Ombitasvir
Ombitasvir was administered orally to pregnant mice (0, 15, 50, or 150 mg/kg/day) and rabbits (0, 10 or 60 mg/kg/day) during the period of organogenesis (on gestation days (GD) 6 to 15, and GD 7 to 19, respectively). There were no ombitasvir-related maternal or embryofetal effects (malformations or fetal toxicity) at any dose level in either species. The systemic exposures at the highest doses were 29-times higher (mice) and 4-times higher (rabbits) than the exposures in humans at the recommended clinical dose.
In a pre- and postnatal developmental study in mice, ombitasvir was administered orally at 0, 10, 40, or 200 mg/kg/day from GD 6 to lactation day 20. There were no ombitasvir-related effects at maternal exposures 26-times higher than exposures in humans at the recommended clinical dose.
The major human metabolites of ombitasvir, M29 and M36, were tested in pregnant mice during the period of organogenesis from GD 6 to 15. M29 was administered orally at doses of 0, 1, 2.5 or 4.5 mg/kg/day. M36 was dosed orally at doses 1.5, 3, or 6 mg/kg/day. In both cases, there were no treatment related maternal effects or embryofetal effects (malformations or fetal toxicity) at any dose level. The highest doses produced exposures approximately 26- times higher than the exposures in humans at the recommended clinical dose.
Paritaprevir/ritonavir
Paritaprevir/ritonavir was administered orally to pregnant rats (0/0, 30/15, 100/15, 450/45 mg/kg/day) and mice (0/0, 30/30, 100/30, or 300/30 mg/kg/day) during the period of organogenesis (on GD 6 to 17, and GD 6 to 15, respectively). There were no test article- related maternal or embryofetal effects (malformations or fetal toxicity) at any dose level in either species. The highest systemic exposure of paritaprevir was 12-times higher (rats) and 143-times higher (mice) than the exposures in humans at the recommended clinical dose.
In a pre- and postnatal developmental study in rats, paritaprevir/ritonavir were administered orally at 0/0, 6/30, 30/30, or 300/30 mg/kg/day from GD 7 to lactation day 20. There were no treatment related effects at maternal exposures 24-times higher than exposures in humans at the recommended clinical dose.
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
It is not known whether TECHNIVIE and its metabolites are present in human breast milk, affect human milk production or have effects on the breastfed infant…
If TECHNIVIE is administered with ribavirin, the nursing mother’s information for ribavirin also applies to this combination regimen. Refer to the ribavirin prescribing information for more information on use during lactation.
Data
Animal Data
Ombitasvir
No effects of ombitasvir on growth and postnatal development were observed in nursing pups at the highest dose tested, 200 mg/kg/day. Maternal systemic exposure (AUC) to ombitasvir was approximately 26 times the exposure in humans at the recommended clinical dose. Although not measured directly, ombitasvir was likely present in the milk of lactating mice in this study, since systemic exposure was observed in nursing pups on post-natal day 21 (approximately 3-16 % of the maternal exposure).
When administered to lactating rats 10 to 11 days after parturition at a dose of 5 mg/kg, the 24 hr AUC in milk was 4 times higher than in plasma and the majority of the radioactivity in the milk was unchanged parent drug (91%).
Paritaprevir/ritonavir
No effects of paritaprevir/ritonavir on growth and postnatal development were observed in nursing pups at the highest dose tested 300/30 mg/kg/day paritaprevir/ritonavir. Maternal systemic exposure (AUC) to paritaprevir was approximately 24 times the exposure in humans at the recommended clinical dose. Although not measured directly, paritaprevir was likely present in the milk of lactating rats at the high dose in this study, since systemic exposure was observed in nursing pups on post-natal day 15 (approximately 0.3 % of the maternal exposure).
When administered to lactating rats 10 to 11 days after parturition at a dose of 30/15 mg/kg paritaprevir/ritonavir, the 24 hr AUC in milk was half that in plasma and the majority of the radioactivity in the milk was the hydrolysis product M13 (84%) followed by unchanged parent drug (16%).
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
If TECHNIVIE is administered with ribavirin, the information for ribavirin with regard to pregnancy testing, contraception, and infertility also applies to this combination regimen. Refer to ribavirin prescribing information for additional information.
(Additions and/or revisions are underlined)
No dosage adjustment of TECHNIVIE is warranted in geriatric patients. Clinical studies PEARL-I and AGATE-1 did not include sufficient numbers of patients older than 65 years of age to assess safety or efficacy, or to determine if they responded differently than younger patients.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE(Additions and/or revisions are underlined)
Common side effects of TECHNIVIE when used with ribavirin include:
headache
change in mood
itching
trouble breathing
muscle or joint pain
skin reactions
dizziness
Who should not take TECHNIVIE?
Do not take TECHNIVIE if you:
• have moderate or severe liver problems
• take any of the following medicines:
Additions underlined:
- carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®, TEGRETOL-XR®, TERIL®)
- cisapride (Propulsid®) trademark
- colchicine (Colcrys®) in patients who have certain kidney or liver problems
- dronedarone (Multaq®) spelling
02/14/2017 (SUPPL-8)
Boxed Warning
(Newly added section)
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
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.
5 Warnings and Precautions
5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV(Newly added subsection)
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.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION(Additions and/or revisions are underlined)
Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of hepatitis B virus infection.
(Additions and/or revisions are underlined)
What is the most important information I should know about TECHNIVIE?
TECHNIVIE can cause serious side effects, including,
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 of hepatitis C virus with TECHNIVIE. Hepatitis B virus becoming 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.
For more information about side effects, see the section “What are the possible side effects of
TECHNIVIE?”
What should I tell my healthcare provider before taking TECHNIVIE?
Before taking TECHNIVIE, tell your healthcare provider about all of your medical conditions, including if you:
- have ever had hepatitis B virus infection
What are the possible side effects of TECHNIVIE?
TECHNIVIE can cause serious side effects, including:
- Hepatitis B virus reactivation. See “What is the most important information I should know about TECHNIVIE?”
06/21/2016 (SUPPL-4)
4 Contraindications
Table 2 (Drugs that are Contraindicated with TECHNIVIE)Four drug classes added; please refer to label.
- Anti-anginal (Ranolazine)
- Antiarrhythmic(Dronedarone)
- Antipsychotic (Lurasidone, and Pimozide)
- GI Motility Agent (Cisapride)
7 Drug Interactions
Drugs without Clinically Significant Interactions with TECHNIVIE- No dosage adjustments are recommended when TECHNIVIE is co-administered with the following medications: addition of abacavir, dolutegravir, lamivudine, sofosbuvir, sulfamethoxazole, and trimethoprim.
Table 4. Established Drug Interactions Based on Drug Interaction Trials
Two drug classes added; please refer to label.
- ANTIDIABETIC DRUGS (metformin)
- MUSCLE RELAXANTS (carisoprodol, and cyclobenzaprine)
The following two drug classes had drugs added; please refer to label.
- NARCOTIC ANALGESICS (Hydrocodone/acetaminophen)
- SEDATIVES/HYPNOTICS (Diazepam)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MG - How should I take TECHNIVIE? (additions)- It is important that you do not miss or skip doses of TECHNIVIE during treatment.
- If you take too much TECHNIVIE, call your healthcare provider or go to the nearest hospital emergency room right away.
Do not take TECHNIVIE if you: (addition)
- cisapride (Propulsid®)
- Advise patients to take TECHNIVIE every day at the regularly scheduled time with a meal without regard to fat or calorie content.
- Inform patients that it is important not to miss or skip doses and to take TECHNIVIE for the duration that is recommended by the healthcare provider.
- Advise patients to avoid pregnancy during treatment and within 6 months of stopping treatment with TECHNIVIE with ribavirin. (addition)