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Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir

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WARNING

You might already have hepatitis B (a virus that affects the liver and can result in serious liver damage), but you might not be aware of it. In this instance, taking dasabuvir, ombitasvir, paritaprevir, and ritonavir concurrently may raise your risk of developing symptoms and a more serious or life-threatening infection. If you have or have previously had a hepatitis B virus infection, let your doctor know. To determine whether you currently have or have ever had hepatitis B, your doctor will conduct a blood test. Throughout and for a few months after your treatment, your doctor will continue to keep an eye out for any symptoms of hepatitis B infection. Your doctor might prescribe you medication to treat this infection before and during your course of dasabuvir, ombitasvir, paritaprevir, and ritonavir, if necessary. Call your doctor right away if you suffer any of the following symptoms during or following your treatment: extreme fatigue, skin or eye yellowing, appetite loss, nausea or vomiting, pale stools, stomach pain, or dark urine are some symptoms to watch out for.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir, your doctor may prescribe specific tests prior to, during, and after your therapy.

Discuss the potential risks of taking dasabuvir, ombitasvir, paritaprevir, and ritonavir with your doctor.

Why is this medication prescribed?

Ribavirin (Copegus, Rebetol, Ribasphere) is used alone or in combination with dasabuvir, ombitasvir, paritaprevir, and ritonavir to treat chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus). The NS5B polymerase inhibitor dasabuvir is non-nucleoside. It functions by lowering the body’s level of HCV. Ombitasvir is an NS5A inhibitor for the hepatitis C virus (HCV). It functions by preventing the spread of the hepatitis C virus within the body. One inhibitor of proteases is paritaprevir. It functions by lowering the body’s level of HCV. An inhibitor of proteases is ritonavir. In order for the medication to work more effectively, it can assist to enhance the body’s level of paritaprevir.

How should this medicine be used?

Extended-release (long-acting) tablets containing dasabuvir, ombitasvir, paritaprevir, and ritonavir are available for oral administration. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. At about the same time each day, take dasabuvir, ombitasvir, paritaprevir, and ritonavir. Never take it in larger or less amounts or more frequently than directed by your doctor.

The container of 28 extended-release tablets contains the medicine. Dasabuvir, ombitasvir, paritaprevir, and ritonavir are each present in a different combination in each of the three tablets that make up a daily dose pack. Each morning, take three tablets each of dasabuvir, ombitasvir, paritaprevir, and ritonavir with meals. Observe the directions on each daily dose pack for taking the tablets out.

Do not split, chew, or crush the extended-release pills; instead, swallow them whole.

Even if you feel good, keep taking dasabuvir, ombitasvir, paritaprevir, and ritonavir. Depending on your health, how well you respond to the drug, and whether you encounter serious side effects, the course of your therapy (12 to 24 weeks) will be determined. Without consulting your doctor, do not discontinue taking dasabuvir, ombitasvir, paritaprevir, and ritonavir.

For a copy of the manufacturer’s information for the patient, ask your chemist or doctor.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking dasabuvir, ombitasvir, paritaprevir, and ritonavir,

  • Inform your doctor and chemist if you have any allergies to any medications, including dasabuvir, ombitasvir, paritaprevir, and ritonavir extended-release tablets, as well as any of its constituents. Your doctor will likely advise against taking dasabuvir, ombitasvir, paritaprevir, and ritonavir if you experienced a severe or life-threatening reaction to ritonavir (rash, blistering, or peeling of the skin). For a list of the ingredients, consult your pharmacist or the Medication Guide.
  • Inform your doctor if you are taking any of the following medications: cisapride (Propulsid), atorvastatin (Lipitor, in Caduet), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), alfuzosin (Uroxatral), apalutamide (Erleada); dronedarone (Multaq), efavirenz (Sustiva, in Atripla), ergotamine (Ergomar, in Cafergot, in Migergot), and methylergonovine (Methergine), all of which were once accessible in the United States but are no longer; oral contraceptives containing ethinyl estradiol, such as some “birth control pills,” patches, hormonal vaginal rings, and other medications; midazolam (by mouth), phenytoin (Dilantin, Phenytek), phenobarbital, gemfibrozil (Lopid), lomitapide (Juxtapid), lovastatin (Altoprev), lurasidone (Latuda); everolimus (Afinitor, Zortress); sildenafil (Revatio) to treat pulmonary arterial hypertension, ranolazine (Ranexa), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), simvastatin (Flolipid, Zocor, in Vytorin), and pimozide (Orap); tacrolimus (Astagraf XL, Envarsus XR, Prograf), St. John’s wort, sirolimus (Rapamune), or triazolam (Halcion). Moreover, let your doctor know if you have liver or renal illness and are taking colchicine (Colcrys, Mitigare). If you are taking one or more of these drugs, your doctor will probably advise you not to take dasabuvir, ombitasvir, paritaprevir, and ritonavir.
  • Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: Alprazolam (Xanax); acetaminophen and hydrocodone (Anexsia, Zyfrel); angiotensin receptor blockers (ARBs), such as valsartan (Diovan, in Diovan HCT, in Exforge), candesartan (Atacand, in Atacand HCT), or losartan (Cozaar, in Hyzaar); warfarin (Coumadin, Jantoven) and other anticoagulants (often known as “blood thinners”); buprenorphine and naloxone (Suboxone, Zubsolv); calcium channel blockers such verapamil (Calan, Verelan, etc.); amlodipine (Norvasc); diltiazem (Cardizem, Dilacor, Tiazac, etc.); nifedipine (Adalat, Procardia); and carisoprodol (Soma); elagolix (Orilissa), cyclobenzaprine (Amrix), cyclosporine (Gengraf, Neoral, Sandimmune), diazepam (Valium), encorafenib (Braftovi), fostamatinib (Tavalisse), and cyclobenzaprine; ibrutinib (Imbruvica), fluticasone (Flonase, Flovent, in Advair), furosemide (Lasix), ivosidenib (Tibsovo); ketoconazole; drugs for irregular heartbeats including amiodarone (Nexterone, Pacerone), bepridil (no longer sold in the United States), disopyramide (Norpace), flecainide, lidocaine (Xylocaine), mexiletine, propafenone (Rythmol), or quinidine (in Nuedexta); quetiapine (Seroquel); rilpivirine (Edurant; in Complera, in Odefsey); metformin (Glucophage, Riomet, among others); omeprazole (Prilosec); pravastatin (Pravachol); iopinavir (in Kaletra) and ritonavir (Norvir, in Kaletra), together with salmeterol (Serevent, in Advair), atazanavir (Reyataz), darunavir (Prezista), and voriconazole, are all HIV protease inhibitors (Vfend). Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • If you have a liver illness other than hepatitis C, let your doctor know. Your doctor could advise against taking ritonavir, dasabuvir, ombitasvir, and paritaprevir.
  • Inform your doctor if you have ever undergone a liver transplant, have diabetes, or have HIV/AIDS (HIV).
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor right away if you become pregnant while taking dasabuvir, ombitasvir, paritaprevir, and ritonavir.
  • You should be aware that ritonavir, paritaprevir, ombitasvir, and dasabuvir may lessen the efficacy of hormonal contraceptives (birth control pills, patches, rings, implants, injections, and intrauterine devices). While taking dasabuvir, ombitasvir, paritaprevir, and ritonavir as well as for two weeks following your last dosage, use a different method of birth control. Discuss with your doctor the birth control methods that will be effective for you both during and after your dasabuvir, ombitasvir, paritaprevir, and ritonavir medication.
  • Do not consume alcohol within 4 hours of taking extended-release tablets of dasabuvir, ombitasvir, paritaprevir, and ritonavir.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

It’s critical to take each dose as prescribed. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There may be negative effects from dasabuvir, ombitasvir, paritaprevir, and ritonavir. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Having trouble falling or staying asleep
  • Cough
  • Irritability
  • Headache
  • Diarrhea
  • Muscles cramping

Certain adverse effects can be very harmful. Call your doctor right away if you encounter any of these signs or any of the ones in the IMPORTANT CAUTION section.

  • Rash
  • Skin turning crimson
  • Itching
  • Hives
  • Weariness or little energy
  • Weakness
  • Confusion

Further negative effects could be brought on by ritonavir, dasabuvir, ombitasvir, and paritaprevir. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly packed in the carton it was packaged in and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom). Till you’re ready to take them, keep the tablets in the daily dose pack that the manufacturer has provided.

All medications should be kept out of the sight and reach of children, as many of the containers (such as weekly pill containers and those for eye drops, lotions, patches, and inhalers) are not child-resistant and are simple for small children to open. Always lock safety caps and put the medication in a secure spot right away, up high and out of young children’s sight and reach, to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

No one else should take your medication. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Viekira XR® (as a combination product containing Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir)
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