Irinotecan liposome (Intravenous)

Irinotecan liposome injection is used with other medicines (for example, fluorouracil, leucovorin) to treat metastatic cancer (cancer that has spread) of the pancreas in patients who have already had gemcitabine-based treatment.

Irinotecan liposome is part of a group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed. This medicine may also affect the growth of normal cells, leading to other effects. Some of these effects can be serious and should be reported to your doctor.

This medicine should only be given by or under the direct supervision of your doctor.

It is very important for your doctor to check your progress during regular visits to ensure that this medicine is working properly. You may need blood tests to monitor for unwanted effects.

Taking this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is taking it when his partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 7 months after the last dose. Male patients with female partners should use effective birth control (for example, condoms) during treatment with this medicine and for 4 months after the last dose. If you think you may be pregnant while receiving this medicine, inform your doctor immediately.

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

This medicine will reduce the number of certain types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these issues, avoid being around people who are sick or have infections. Wash your hands frequently. Stay away from rough sports or situations where you could get bruised, cut, or injured. Brush and floss your teeth gently. Be cautious when using sharp objects, including razors and fingernail clippers.

This medicine may cause severe diarrhea. Do not take any medicine to treat diarrhea without first consulting your doctor. If you have any questions about this or if mild diarrhea continues or worsens, check with your doctor.

This medicine may lead to a serious lung or breathing problem (for example, interstitial lung disease). Contact your doctor right away if you experience cough, difficulty breathing, or fever.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and needs immediate medical attention. Call your doctor right away if you experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while receiving this 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 (for example, St John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide.

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the effects of irinotecan liposome injection in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of irinotecan liposome injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor might adjust the dose or take other precautions. When you are receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on 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 prescribe this medication or may change some of your other medicines.

• Atazanavir
• Itraconazole
• Ketoconazole
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

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

• Abametapir
• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Boceprevir
• Carbamazepine
• Cholera Vaccine, Live
• Clarithromycin
• Cobicistat
• Conivaptan
• Dengue Tetravalent Vaccine, Live
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Indinavir
• Influenza Virus Vaccine, Live
• Lopinavir
• Mavacamten
• Nefazodone
• Nelfinavir
• Netupitant
• Omaveloxolone
• Phenobarbital
• Phenytoin
• Poliovirus Vaccine, Live
• Posaconazole
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• Smallpox Vaccine
• St John's Wort
• Telaprevir
• Telithromycin
• Tipranavir
• Typhoid Vaccine, Live
• Voriconazole
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Rolapitant

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food because interactions may happen. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Lung or breathing problems (e.g., interstitial lung disease)—Use with caution. This may worsen the condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Confusion
• decreased urination
• diarrhea (severe)
• dizziness
• dry mouth
• fainting
• fever
• lightheadedness
• pale skin
• rapid breathing
• sunken eyes
• thirst
• trouble breathing
• unusual bleeding or bruising
• 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
• rapid, shallow breathing
• slow or irregular heartbeat
• sore throat
• trouble breathing
• ulcers, sores, or white spots in the mouth

Incidence not known

• Chest tightness
• hives, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• reddening of the skin, especially around the ears

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to provide ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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

• Feeling of warmth
• increased sweating
• sneezing
• stomach pain
• stuffy or runny nose
• tearing of the eyes
• watering of the mouth
• weakness

Other side effects not listed may also happen 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.

In the U.S.

• Onivyde

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Topoisomerase I Inhibitor

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.

Your doctor may give you other medicines (eg, steroid medicine, medicine to prevent nausea and vomiting) 30 minutes before receiving this medicine.