Before you take Rinteca

Do not take Rinteca

• If you are allergic to Irinotecan Hydrochloride Trihydrate or any of the other ingredients of Rinteca (listed in section 6)
• If you have chronic inflammatory bowel disease and/or bowel obstruction
• If you are a breast-feeding woman
• If your bilirubin level is higher than 3 times the upper limit of the normal range
• If you have severe bone marrow failure
• If you are in poor general condition
• If you are taking or have recently taken

St john’s wort (a herbal extract containing hypericum)

• If you are to take or have recently taken live attenuated vaccines (vaccines against yellow fever, chicken pox, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza) and during the 6 months after stopping chemotherapy.

 

 

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Rinteca. Take special care with Rinteca. The use of Rinteca should be confined to units specialized in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy.

 

Diarrhea: Rinteca can cause diarrhea, which in some cases may be severe. This may start a few hours or a couple of days after the medicine infusion. If left untreated, it could lead to dehydration and serious chemical imbalances, which can be life threatening. Your doctor will prescribe medicine to help prevent or control this side effect. Make sure you get the medicine right away, so that you will have it at home when you need it. Take the medicine as prescribed at the first sign of loose or frequent bowel movements. Drink large amounts of water and (or) salty drinks (fizzy water, soda or soup). Call your doctor or nurse know if you still have diarrhea, especially if it lasts more than 24 hours, or if you get lightheaded, dizzy, or faint.

 

Neutropenia: This medicine can lower your white blood cell count, mainly in the weeks after the medicine is given. This can increase the risk of getting an infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (38°C or higher), chills, pain when passing urine, cough, or bringing up sputum. Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

 

Blood monitoring: Your doctor will likely test your blood before and during your treatment, to check for effects of the medicine on blood counts or on blood chemistry. Based on the test results, you may need medicines to help treat the effects. Your doctor may also need to reduce or delay your next dose of this medicine, or even stop it. Keep all your appointments for doctor visits and lab tests. This medicine may lower your platelet count in the weeks after it is given, which can increase your risk of bleeding. Speak with your doctor before taking any medicines or supplements that might affect your body’s ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin or vitamin E. Tell your doctor right away if you have unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

Nausea and vomiting: You may have nausea and vomiting on the day you receive this medicine or in the first few days after. Your doctor may give you medicine before your treatment to help prevent nausea and vomiting. Your doctor will likely prescribe anti-nausea medicines that you can take at home. Have these medicines on hand for when you need them. Call your doctor if you are unable to take fluids by mouth due to nausea and vomiting.

 

Acute cholinergic syndrome: This medicine may affect part of your nervous system that controls body secretions, leading to what is known as cholinergic syndrome. Symptoms can include runny nose, increased saliva, excess tears in the eyes, sweating, flushing, abdominal cramps, and diarrhea. Let your doctor or nurse know right away if you notice any of these symptoms, as there are medicines that can help control them.

 

Lung disorders: Rarely, people on this medicine have serious lung problems, tell your doctor right away if you have new or worsening cough, trouble breathing, and fever. Your doctor may need to stop your treatment to manage this problem. This medicine may increase your risk of blood clots in the veins of the legs or lungs, which can travel to other parts of the body such as the brain. Tell your doctor right away if you notice chest pain, shortness of breath, or swelling, pain, redness, or warmth in the arm or leg.

 

Chronic intestinal inflammation and/or intestinal blockage: Call your doctor if you have pain in your belly and you cannot move your bowels, especially if you also have bloating and loss of appetite.

Irradiation therapy: If you recently received treatment with pelvic or abdominal radiotherapy, you may be at increased risk of developing bone marrow suppression. Talk to your doctor before starting Rinteca.

 

Kidney function: Occurrences of kidney dysfunction have been reported.

 

Cardiac disorders: Inform your doctor if you suffer/suffered from heart disease or if you previously received anticancer medicines. Your doctor will monitor you closely and discuss with you how risk factors (for example smoking, high blood pressure and high fat content) can be reduced.

 

 

Vascular disorders: Rinteca is rarely associated with blood flow disorders (blood clots in the vessels of your legs and lungs) and it may occur rarely in patients with multiple risks factors.

 

Others: This medicine may cause sores in the mouth or on the lips, often within the first few weeks after starting treatment. This can cause mouth pain, bleeding, or even trouble eating. Your doctor or nurse can suggest ways to reduce this, such as changing the way you eat or how you brush your teeth. If needed, your doctor can prescribe medicine to help with the pain.

Tell your doctor or dentist that you are on this medicine if you are planning to have surgery. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

 

Other medicines and Rinteca

Rinteca can interact with a number of medicines and supplements, which may either raise or lower the level of the medicine in your blood. Tell your doctor or pharmacist if you are using, have recently used or might use any of the following:

Carbamazepine, Phenobarbital, Phenytoin, Fosphenytoin, Ketoconazole, Itraconazole, Voriconazole, Posaconazole, Clarithromycine, Erythromycin, Telithromycine, Rifampicin, Rifabutin, St. John’s Wort (a herbal dietary supplement), Live attenuated vaccines, Indinavir, Ritonavir, Amprenavir, Fosamprenavir, Nelfinavir, Atazanavir, Cyclosporine, Tacrolimus, Regorafenib, Crizotinib, Idelalisib, Warfarin, Suxamethonium, 5-Fluorouracil/ Folinic acid, Bevacizumab and Cetuximab.

Don’t start or stop taking any medicines while you are on Rinteca without talking with your doctor first.

This medicine can cause serious diarrhea.

Try to avoid laxatives and stool softeners while taking Rinteca.

Pregnancy, breast-feeding and fertility

You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy up to 1 month and 3 months after treatment, because Rinteca may be harmful for the unborn baby. It is important to check with your doctor about what kinds of birth control can be used with this medicine. In pregnant women, treatment with this medicine should be used only if the potential benefit to the mother outweighs the risk to the fetus. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You must not breast-feed while you are treated with Rinteca, because it is not known if Rinteca passes into breast milk. Due to the possibility of harm to the infant stop breast-feeding and do not restart breast-feeding unless your doctor has allowed you to.

No studies have been done, nevertheless, this medicine may affect fertility. Talk with your doctor about the possible risk with this medicine and the options that may preserve your ability to have children.

 

 

Driving and using machines

You may notice that you are dizzy and/or have trouble with your vision in the first

24 hours or so after you take Rinteca. Do not drive or operate machinery if you have this side effect.

 

Rinteca contains Sorbitol

This medicine contains a sugar (Sorbitol). Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects. You must tell your doctor before receiving Rinteca if you have HFI.