What is ELOXATIN?
ELOXATIN is an anti-cancer (chemotherapy) medicine that is used with other anti-cancer medicines called fluorouracil and leucovorin to treat people with:
- stage III colon cancer after surgery to remove the tumor
- advanced colon or rectal cancer (colorectal cancer)
- It is not known if ELOXATIN is effective in children.
Who should not receive ELOXATIN?
Do not receive ELOXATIN if you are allergic to any of the ingredients in ELOXATIN or other medicines that contain platinum. See the end of this leaflet for a complete list of the ingredients ELOXATIN. Ask your doctor if you are not sure if you take a medicine that contains platinum.
What should I tell my doctor before receiving ELOXATIN?
Before receiving ELOXATIN, tell your doctor about all of your medical conditions, including if you:
- have an infection
- have lung, liver, or kidney problems
- have bleeding problems
- have or had heart problems such as an abnormal heart test called an electrocardiogram (ECG or EKG), a condition called long QT syndrome, an irregular or slow heartbeat, or a family history of heart problems.
- have had changes in the level of certain blood salt (electrolytes) levels, including potassium, magnesium, and calcium
- are pregnant or plan to become pregnant. ELOXATIN may harm your unborn baby. Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with ELOXATIN.
- if you are able to become pregnant, your doctor may do a pregnancy test before you start treatment with ELOXATIN and for 9 months after the final dose. Talk to your doctor about forms of birth control that may be right for you.
- Females who are able to become pregnant should avoid becoming pregnant and should use effective birth control during treatment with ELOXATIN and for 9 months after the final dose. Talk to your doctor about forms of birth control that may be right for you.
- Males with female partners who are pregnant or able to become pregnant should use effective birth control during treatment with ELOXATIN and for 6 months after the final dose.
- ELOXATIN may cause fertility problems in males and females. Talk to your doctor if this is a concern for you.
- are breastfeeding or plan to breastfeed. It is not known if ELOXATIN passes into your breast milk. Do not breastfeed during treatment with ELOXATIN and for 3 months after the final dose.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How will I receive ELOXATIN?
- ELOXATIN is given to you into your vein through an intravenous (IV) tube.
- Your doctor will prescribe ELOXATIN in a dose that is right for you.
- Your doctor may change how often you receive ELOXATIN, your dose, or how long your infusion will take.
- It is very important that you do exactly what your doctor and nurse tell you to do.
- Some medicines may be given to you before ELOXATIN to help prevent nausea and vomiting
- Each treatment course is given to you over 2 days. You will receive ELOXATIN on the first day only.
- There are usually 14 days between each chemotherapy treatment course.
- It is important for you to keep all of your medical appointments. Call your doctor if you miss an appointment. There may be special instructions for you.
What should I avoid while receiving ALIQOPA?
- Avoid taking St. John’s Wort during treatment with ALIQOPA.
- Avoid drinking grapefruit juice during treatment with ALIQOPA.
What are the possible side effects of ALIQOPA?
ALIQOPA can cause serious side effects, including:
- Infections. ALIQOPA can cause serious infections that may lead to death. The most common serious infection was pneumonia. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with ALIQOPA.
- High blood sugar (hyperglycemia). High blood sugar is common following ALIQOPA infusion and can sometimes be serious. Tell your healthcare provider if you develop any symptoms of hyperglycemia during treatment with ALIQOPA. Symptoms of hyperglycemia may include:
- being very hungry
- headaches
- being very thirsty
- frequent urination
- High blood pressure (hypertension). High blood pressure is common following ALIQOPA infusion and can sometimes be serious.
- Lung or breathing problems. Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with ALIQOPA. Tell your healthcare provider right away if you develop new or worsening cough, shortness of breath, or difficulty breathing.
- Low white blood cell count (neutropenia). Neutropenia is common with ALIQOPA treatment and can sometimes be serious. Your healthcare provider will check your blood counts regularly during treatment with ALIQOPA. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with ALIQOPA.
- Severe skin reactions. Skin peeling, rash, and itching are common with ALIQOPA and can sometimes be serious. Tell your healthcare provider if you develop skin peeling, itching, or rash during treatment with ALIQOPA. Your healthcare provider may withhold treatment, decrease your dose, or permanently stop treatment if you develop severe skin reactions during treatment with ALIQOPA.
The most common side effects of ALIQOPA include:
- low white blood cell count (leukopenia)
- low platelets in your blood (thrombocytopenia)
- diarrhea
- decreased strength and tiredness
- lower respiratory tract infection
- nausea
These are not all of the possible side effects of ALIQOPA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ALIQOPA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about ALIQOPA that is written for health professionals.
What are the ingredients in ALIQOPA?
- Active ingredient: copanlisib
- Inactive ingredients: citric acid anhydrous, mannitol, sodium hydroxide
Tell your healthcare provider if you have vomiting, diarrhea, or signs of dehydration that does not go away. ABRAXANE may cause fertility problems in males and females, which may affect your ability to have a child.
Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of ABRAXANE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ask your healthcare provider if you do not know.