Description
Irinotecan liposome injection is used in combination with other medicines (eg, fluorouracil, leucovorin, and oxaliplatin) as first-line treatment of metastatic cancer (a cancer that has already spread) of the pancreas. This medicine is also used in combination with other medicines (eg, fluorouracil, leucovorin) to treat metastatic cancer of the pancreas in patients who have received gemcitabine-based treatment.
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.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Breastfeeding
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.
Drug Interactions
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
- 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 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.
- Abametapir
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Apalutamide
- Avacopan
- Bacillus of Calmette and Guerin Vaccine, Live
- Boceprevir
- Carbamazepine
- Ceritinib
- Cholera Vaccine, Live
- Clarithromycin
- Cobicistat
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Enzalutamide
- Fedratinib
- Fexinidazole
- Fosnetupitant
- Fosphenytoin
- Gemfibrozil
- Idelalisib
- Indinavir
- Influenza Virus Vaccine, Live
- Ivacaftor
- Ivosidenib
- Lonafarnib
- Lumacaftor
- Mavacamten
- Mifepristone
- Mitotane
- Nefazodone
- Nelfinavir
- Netupitant
- Omaveloxolone
- Paritaprevir
- Phenobarbital
- Phenytoin
- Poliovirus Vaccine, Live
- Posaconazole
- Primidone
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Rolapitant
Other Interactions
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:
- Lung or breathing problems (eg, interstitial lung disease)—Use with caution. May make this condition worse.
Proper Use
A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through an IV catheter that is placed in one of your veins. The medicine must be injected slowly, so your IV 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.
Precautions
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.
Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual 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 who have female partners should use effective birth control (eg, condoms) during treatment with this medicine and for 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
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 will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful 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 checking with your doctor. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
This medicine may cause a serious lung or breathing problem (eg, interstitial lung disease). Check with your doctor right away if you have cough, difficulty breathing, or fever.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are 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 (eg, St John's wort) or vitamin supplements.
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
- Bleeding gums
- confusion
- coughing up blood
- decreased urination
- diarrhea (severe)
- difficulty in swallowing
- dizziness
- dry mouth
- fainting
- fever
- headache
- increased menstrual flow or vaginal bleeding
- lightheadedness
- nosebleeds
- pale skin
- paralysis
- prolonged bleeding from cuts
- rapid breathing
- red or black, tarry stools
- red or dark brown urine
- sunken eyes
- thirst
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- wrinkled skin
Less common
- 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
- 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 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
- Constipation
- cracked lips
- 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 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.
CON-XXXXXXXX
