Onivyde

Onivyde is a prescription medication used in combination with fluorouracil and leucovorin, to treat patients with advanced pancreatic cancer.

Onivyde belongs to a group of drugs called topoisomerase I inhibitors. These work by stopping the growth of cancer cells.

This medication is available as a liquid to be given intravenously (into a vein) by a healthcare professional.

Common side effects of Onivyde include diarrhea, fatigue, and vomiting.

Onivyde is a prescription medication used in combination with fluorouracil and leucovorin, to treat patients with advanced pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

Onivyde is not indicated as a single agent for the treatment of patients with advanced pancreatic cancer. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Onivyde. See the “Onivyde Precautions” section.

Common side effects of Onivyde include the following:

• diarrhea
• fatigue
• vomiting
• nausea
• a decrease in appetite
• inflammation inside the mouth
• fever
• a decrease in lab counts

This is not a complete list of Onivyde side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• medications that inhibit UGT1A1 such as atazanavir, gemfibrozil, and indinavir

This is not a complete list of Onivyde drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Onivyde including the following: 

• severe diarrhea. Tell your doctor right away if you have persistent vomiting or diarrhea; black or bloody stools; or symptoms of dehydration such as lightheadedness, dizziness, or faintness.
• a decrease in the number of blood cells made by your bone marrow. Tell your doctor right away if you experience any of the following symptoms: fever, chills, cough, or other signs of infection; shortness of breath; fast heartbeat; headache; dizziness; pale skin; confusion; extreme tiredness, or unusual bleeding or bruising.
• interstitial Lung Disease. Tell your doctor right away if you notice a new cough or difficulty breathing. 
• harmful to your unborn baby. Based on animal data, Onivyde may cause harm to the unborn baby when given to a pregnant woman. Females of reproductive age should use an effective form of contraception during and for 1 month after Onivyde treatment.  
• severe allergic reactions. Onivyde may cause severe allergic reactions. Get immediate medical attention if you experience chest tightness; shortness of breath; wheezing; dizziness or faintness; or swelling of the face, eyelids, or lips. 

Do not take Onivyde if you are allergic to Onivyde or to any of its ingredients

Your doctor will tell you about a special diet to follow to help control diarrhea during your treatment. Follow these instructions carefully.

Grapefruit and grapefruit juice may interact with this medication and can lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Onivyde, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Onivyde or to any of its ingredients
• have or had a bowel obstruction
• have UGT1A1*28 allele 
• take St. John's wort
• take medications that block a protein in the body (CYP3A4) such as ketoconazole, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, and voriconazole
• take medications that increase the activity of the enzyme CYP3A4 such as phenytoin, rifampin, carbamazepine, rifabutin, rifapentine, and phenobarbital
• take medications that inhibit UGT1A1 such as atazanavir, gemfibrozil, and indinavir
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Based on animal data, Onivyde may cause harm to the unborn baby when given to a pregnant woman. Females of reproductive age should use an effective form of contraception during and for 1 month after Onivyde treatment.  

Males with females reproductive age should use condoms during treatment with Onivyde and for 4 months after the final dose of Onivyde.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Onivyde crosses into human milk. Because of the potential Because of the potential for serious adverse reactions in breastfed infants from Onivyde, women should not breastfeed during treatment with  Onivyde and for one month after the final dose of Onivyde.

Onivyde is available as a liquid to be given intravenously (into a vein) by a healthcare professional.

It is given over 90 minutes every 2 weeks. 

If you miss an appointment, call your doctor to ensure you receive your treatment. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your body surface area

The recommended dose of Onivyde (irinotecan HCl) is 70 mg/m².

The recommended dose range of Onivyde (irinotecan HCl) for patients with the UGT1A1*28 allele, is  50 mg/m² to 70 mg/m². 

If Onivyde is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Keep all of your appointments.

WARNING: SEVERE NEUTROPENIA and SEVERE DIARRHEA

Fatal neutropenic sepsis occurred in 0.8% of patients receiving Onivyde. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving Onivyde in combination with fluorouracil and leucovorin. Withhold Onivyde for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.

Severe diarrhea occurred in 13% of patients receiving Onivyde in combination with fluorouracil and leucovorin. Do not administer Onivyde to patients with bowel obstruction. Withhold Onivyde for diarrhea of Grade 2-4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.