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Onivyde (Intravenous)

Generic Name: irinotecan liposome (Intravenous route)

eye-ri-noe-TEE-kan LYE-poh-some

Intravenous route(Solution)

Fatal neutropenic sepsis has been reported with irinotecan liposome therapy. Life-threatening neutropenia, life-threatening neutropenic fever or sepsis, and severe diarrhea has been reported with irinotecan liposome therapy in combination with fluorouracil and leucovorin. Monitor blood cell counts periodically. Withhold treatment for absolute neutrophil count below 1500/mm(3), neutropenic fever. Severe diarrhea has been reported. Withhold treatment for grade 2 or higher diarrhea. Administer atropine for early diarrhea and administer loperamide for late diarrhea. Do not administer to patients with bowel obstruction .

Commonly used brand name(s)

In the U.S.

  • Onivyde

Available Dosage Forms:

  • Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Topoisomerase I Inhibitor

Uses For Onivyde

Irinotecan liposome injection is given along with other medicines to treat metastatic cancer (a cancer that has already spread) of the pancreas in patients who have received gemcitabine.

Irinotecan liposome belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious, but may cause concern. Some effects may occur after treatment with irinotecan liposome has been stopped. Be sure that you have discussed with your doctor the possible side effects of this medicine as well as the good it can do.

This medicine is available only with your doctor's prescription.

Before Using Onivyde

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of irinotecan liposome injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of irinotecan liposome injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Atazanavir
  • Itraconazole
  • Ketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Boceprevir
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Fosphenytoin
  • Idelalisib
  • Indinavir
  • Lopinavir
  • Nefazodone
  • Nelfinavir
  • Phenobarbital
  • Phenytoin
  • Posaconazole
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bowel blockage—Should not be used in patients with this condition.
  • Interstitial lung disease—Use with caution. May make this condition worse.

Proper Use of Onivyde

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 90 minutes and it is given every 2 weeks.

Irinotecan liposome often causes nausea and vomiting. However, it is very important that you continue to receive this medicine even if you begin to feel ill. You may receive other medicines to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.

Precautions While Using Onivyde

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 1 month after the last dose of this medicine. Men receiving irinotecan liposome should use condoms as a form of birth control during treatment and for 4 months after your final dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not breastfeed during treatment or for one month after the final dose .

Tell your doctor if you are using a medicine that contains irinotecan. Do not use Onivyde™ to substitute for other medicines containing irinotecan.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause severe diarrhea. Contact your doctor immediately if you have persistent vomiting or diarrhea, black or bloody stools, or symptoms of dehydration such as lightheadedness, fainting, or dizziness. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Tell your doctor right away if you have an unexplained fever, cough, or trouble breathing after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have chest tightness, wheezing, dizziness, chills, fever, hives, hoarseness, itching, rash, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Onivyde Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Confusion
  • decreased urination
  • diarrhea (severe)
  • dizziness
  • dry mouth
  • fainting
  • fever
  • lightheadedness
  • rapid breathing
  • sunken eyes
  • thirst
  • unusual tiredness or weakness
  • wrinkled skin
Less common
  • Black, tarry stools
  • chest pain or discomfort
  • chills
  • confusion
  • cough
  • fast heartbeat
  • lightheadedness, dizziness, or fainting
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • rapid, shallow breathing
  • shortness of breath
  • slow or irregular heartbeat
  • sore throat
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
Incidence not known
  • Difficulty with breathing or swallowing
  • hives, itching, or skin rash
  • nausea
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • reddening of the skin, especially around the ears
  • tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Decreased appetite
  • hair loss or thinning of the hair
  • lack or loss of strength
  • vomiting
  • weight loss
Less common
  • Abdominal or stomach pain
  • feeling of warmth
  • increased sweating
  • runny nose
  • sneezing
  • stuffy nose
  • tearing of the eyes
  • watering of the mouth
  • weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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