VICTRELIS Rx
Generic Name and Formulations:
Boceprevir 200mg; capsules.
Company:
Merck & Co., Inc.
Indications for VICTRELIS:
Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy including prior null responders, partial responders, and relapsers. Not for use as monotherapy.
Adult Dose for VICTRELIS:
≥18yrs: Take with food. 800mg three times daily. Start after 4 weeks therapy with peginterferon and ribavirin. Without cirrhosis: continue treatment as indicated by HCV-RNA levels at Weeks 8, 12, and 24 (see full labeling). With cirrhosis: continue for 44 weeks. Do not reduce dose. Discontinue if HCV-RNA levels indicate futility (see full labeling).
Children's Dose for VICTRELIS:
<18yrs: not recommended.
Pharmacological Class:
HCV NS3/4A protease inhibitor.
Contraindications:
Concomitant potent CYP3A4/5 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) or narrow therapeutic index CYP3A4/5 substrates (eg, alfuzosin, cisapride, ergot derivatives, lovastatin, simvastatin, drosperinone, pimozide, sildenafil or tadalafil for PAH, triazolam, oral midazolam). Pregnant women and men whose partners are pregnant (note: ribavirin is Cat. X). Review peginterferon and ribavirin contraindications.
Warnings/Precautions:
Female patients and partners must have (–) pregnancy test before therapy, use appropriate effective contraception, and undergo monthly pregnancy test. Monitor CBC w. differential, HCV-RNA. If hgb <10g/dL: reduce or interrupt ribavirin; if hgb <8.5g/dL: discontinue ribavirin; if ribavirin permanently discontinued, then peg-interferon alfa and Victrelis must be discontinued. Co-infection with HBV or HIV. Decompensated cirrhosis. Organ transplant recipients. Pregnancy (Cat. B). Nursing mothers: not recommended.
Interactions:
See literature. Concomitant rifabutin, salmeterol, efavirenz, concomitant colchicine in renal or hepatic impairment: not recommended. Potentiates CYP3A4/5 substrates (eg, amiodarone, bepridil, propafenone, quinidine, flecainide, trazodone, desipramine, azole antifungals, clarithromycin). Antagonizes ethinyl estradiol. Antagonized by potent CYP3A4/5 inhibitors. Monitor warfarin, digoxin, dihydropyridine calcium channel blockers, bosentan, protease inhibitors, immunosuppressants, opioids. Concomitant ketoconazole, itraconazole: max 200mg/day. Concomitant atorvastatin: max 40mg/day. Colchicine, PDE5 inhibitors for ED (eg, sildenafil, tadalafil, vardenafil), alprazolam, IV midazolam: reduce doses and monitor. Corticosteroids: avoid, monitor if needed.
Adverse Reactions:
Fatigue, nausea, headache, dysgeusia, worsening anemia, neutropenia; hypersensitivity reactions (discontinue if occurs).
Metabolism:
Hepatic.
Elimination:
Fecal (primarily), renal.
Generic Availability:
NO
How Supplied:
Bottles (12 caps/bottle)—28
How do I take VICTRELIS?
VICTRELIS must be taken in combination with peginterferon alfa and ribavirin to treat chronic hep C (genotype 1).
Therapy with VICTRELIS includes:
Should I take VICTRELIS with food?
Yes. VICTRELIS should be taken with food, such as a meal or light snack.
What if I miss a dose of VICTRELIS?
If you miss a dose and it is less than 2 hours before your next dose is due, the missed dose should be skipped.
If you miss a dose and it is 2 or more hours before the next dose is due, take the missed dose with food and continue the normal dosing schedule. Do not double the next dose. If you have questions about what to do, call your health care provider.
How is VICTRELIS packaged?
VICTRELIS is packaged in a set of 28 bottles.
Each bottle contains a daily supply
of 12 capsules.
VICTRELIS can be stored at room
temperature (up to 3 months) or in
the refrigerator.
Take VICTRELIS exactly as your health care provider tells you to take it. Your health care provider
will tell you how much to take and when to take it.
Read the Medication Guide before you start taking VICTRELIS. Talk to your doctor about any questions you may have about VICTRELIS.
VICTRELIS is a prescription medicine used with the medicines peginterferon alfa and ribavirin (peg/riba) to treat long-lasting (chronic) hepatitis C genotype 1 infection in adults with stable (compensated) liver disease who have not been treated before or who have failed previous treatment. Do not take VICTRELIS alone.
It is not known if VICTRELIS is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
VICTRELIS plus peg/riba may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines.
•Females and males must use 2 effective forms of birth control during treatment and for 6 months after treatment with VICTRELIS plus peg/riba combination therapy. Hormonal forms of birth control such as implants, injections, vaginal rings, and some birth control pills may not work during treatment with VICTRELIS. The use of certain types of birth control pills may be acceptable. Talk to your health care provider about forms of birth control that may be used during this time.
•Females must have a pregnancy test before starting treatment with VICTRELIS plus peg/riba combination therapy, every month while being treated, and every month for 6 months after all treatment is over.
•If you or your female sexual partner becomes pregnant while taking VICTRELIS plus peg/riba combination therapy or within 6 months after you stop taking these medicines, tell your health care provider right away. You or your health care provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.
Before you take VICTRELIS, tell your health care provider if you have blood problems like low red blood cell count (anemia) or a certain type of low white blood cell count (neutropenia), have liver problems other than hepatitis C, have human immunodeficiency virus (HIV) or any other immunity problems, had an organ transplant, plan to have surgery, have any other medical condition, or are breastfeeding. It is not known if VICTRELIS passes into breast milk. You and your health care provider should decide if you will take VICTRELIS or breastfeed. You should not do both.
VICTRELIS may cause serious side effects, including serious allergic reactions and blood problems.
•Serious allergic reactions may become severe, requiring treatment in a hospital. If you experience itching, hives, swelling of the face, eyes, lips, tongue, or throat or have trouble breathing or swallowing, you should tell your health care provider immediately.
•VICTRELIS can affect your bone marrow and cause low red blood cell and low white blood cell counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get anemia or infections.
The most common side effects of VICTRELIS with combination therapy include: tiredness, nausea, headache, and change in taste. Tell your health care provider about any side effect that bothers you or that does not go away. There may be other side effects of VICTRELIS. For more information, ask your health care provider.
Do not take VICTRELIS if you have had an allergic reaction to VICTRELIS. Do not take VICTRELIS if you take certain medicines. VICTRELIS and other medicines may affect each other. This can cause you to have too much or not enough VICTRELIS or your other medicines in your body, affecting the way VICTRELIS and your other medicines work, or causing side effects that can be serious or life threatening.
Tell your health care provider about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start taking a new medicine without telling your health care provider. For a listing of medicines that you should not take with VICTRELIS, please see the Medication Guide.
It is not known if treatment with VICTRELIS will prevent you from infecting another person with the hepatitis C virus during your treatment. Talk with your health care provider about ways to prevent spreading the hepatitis C virus.
Do not take VICTRELIS® (boceprevir) if you take a medicine that contains:
alfuzosin hydrochloride (UROXATRAL®) • anti-seizure medicines: carbamazepine (CARBATROL®, EPITOL®, EQUETRO®, TEGRETOL®, TEGRETOL® XR, TERIL™); phenobarbital; phenytoin (DILANTIN®) • cisapride (PROPULSID®) • drospirenone-containing birth control medicines, including: YAZ®, YASMIN®, ZARAH®, OCELLA®, GIANVI®, BEYAZ®, ANGELIQ®, LORYNA™, SYEDA™, SAFYRAL™ • ergot-containing medicines, including: dihydroergotamine mesylate (D.H.E. 45®, MIGRANAL®); ergonovine and methylergonovine (ERGOTRATE®, METHERGINE®); ergotamine tartrate (CAFERGOT®, MIGERGOT®, ERGOMAR®, ERGOSTAT, MEDIHALER ERGOTAMINE, WIGRAINE, WIGRETTES) • lovastatin (ADVICOR®, ALTOPREV®, MEVACOR®) • midazolam when taken by mouth • pimozide (ORAP®) • rifampin (RIFADIN®, RIFAMATE®, RIFATER®, RIMACTANE) • sildenafil (REVATIO®), when used for treating lung problems • simvastatin (SIMCOR®, VYTORIN®, JUVISYNC™, ZOCOR®) • St. John’s Wort (Hypericum perforatum) or products containing St. John’s Wort • tadalafil (ADCIRCA®), when used for treating lung problems • triazo
