20 mg / mL concentrate for infusion solution
irinotecan
What Irinotecan Fresenius Kabi is and what it is used for
Irinotecan Fresenius Kabi is a cancer drug that contains the active substance irinotecan hydrochloride trihydrate.
Irinotecan hydrochloride trihydrate interferes with the growth and spread of cancer cells throughout the body.
Irinotecan Fresenius Kabi is used in combination with other medicines to treat advanced or metastatic colon or rectal cancer.
Irinotecan Fresenius Kabi can be used alone to treat patients with metastatic cancer of the colon or rectum when the disease has recurred or progressed after initial fluorouracil-based treatment.
Irinotecan contained in Irinotecan Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
Before using Irinotecan Fresenius Kabi
Do not use Irinotecan Fresenius Kabi
- If you have chronic inflammatory bowel disease and / or bowel obstruction
- If you are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients of this medicine (see section 6 “What Irinotecan Fresenius Kabi contains”).
- If you are breast-feeding (see section 2)
- If your bilirubin level is higher than 3 times the upper normal range
- If you have severely impaired bone marrow function
- If you have a reduced general status (WHO’s performance status higher than 2)
- If you are taking or have recently taken (traditional) herbal medicines containing St. John’s wort (Hypericum perforatum)
- if you are receiving or have recently received vaccination with live, attenuated vaccine (vaccine against yellow fever, chickenpox, shingles , measles, mumps, rubella, tuberculosis , rotavirus, influenza ). This also applies if you receive such a vaccination within 6 months after completing chemotherapy .
If you are taking Irinotecan Fresenius Kabi in combination with other medicines, you should also read the package leaflet for these medicines, as they may not be suitable for you.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Irinotecan Fresenius Kabi.
Take special care with Irinotecan Fresenius Kabi. The use of Irinotecan Fresenius Kabi should be limited to departments specializing in chemotherapy and should only be given under the supervision of a qualified physician.
Diarrhea
Irinotecan Fresenius Kabi can cause diarrhea, which in some cases can be severe. Diarrhea may begin a few hours or a few days after you receive an infusion. If left untreated, diarrhea can lead to dehydration and severe chemical imbalances in the body, which can be life-threatening. Your doctor will prescribe medication to prevent or control this side effect. Make sure you get this medicine from your pharmacist immediately, so that you have it at home if you need it.
- Take the medicine as directed by your doctor immediately at the first symptoms of diarrhea or frequent bowel movements.
- Drink large amounts of water and (or) beverages that contain salt (mineral water, soda or soup).
- Contact a doctor or nurse if the diarrhea continues, especially if the diarrhea lasts longer than 24 hours or if you feel dizzy, dizzy or faint.
Neutropenia (a decrease in certain white blood cells )
This medicine can reduce the number of white blood cells, mainly in the weeks after the medicine has been given. This may increase the risk of infection. Tell your doctor or nurse immediately if you get signs of infection, such as fever (38 ° C or higher), chills, pain when urinating, a new cough, or cough with mucus. Avoid being close to people who are sick or have an infection. Tell your doctor immediately if you get any signs of infection.
Follow-up of blood values
The doctor will probably take blood samples before and during treatment to check how the medicine affects the number of blood cells and different blood values. Based on the test results, you may need to take medication to treat these effects. Your doctor may also need to reduce your next dose or give it later, or even stop treatment with this medicine altogether. Go to all doctor visits and samples.
This medicine can reduce the number of platelets in the weeks after it has been given, which may increase the risk of bleeding. Talk to your doctor before taking medications or supplements that can affect the body’s ability to stop bleeding, such as drugs containing aspirin, warfarin, or E vitamin. Tell your doctor immediately if you have unusual bruising or bleeding such as nosebleeds, bleeding gums when brushing your teeth, or black, tar-like stools.
Nausea and vomiting
Nausea and vomiting may occur on the same day as you receive this medicine or in the first few days after you receive it. Before you are given this medicine, your doctor may give you another medicine that prevents nausea and vomiting. Your doctor will probably prescribe medication for nausea and vomiting that you can take at home. Make sure you have these medicines available when you need them. Contact a doctor if you are unable to get fluids due to nausea and vomiting.
Acute cholinergic syndrome
This drug can affect the part of the nervous system that controls body secretions, which can lead to the so-called cholinergic syndrome. Symptoms may include a runny nose, increased saliva production, increased tear flow, sweating, redness, stomach cramps, and diarrhea. Tell your doctor or nurse immediately if you notice any of these symptoms, as there are medicines to treat them.
Lung diseases
In rare cases, this medicine may cause serious lung problems. Tell your doctor immediately if you have a new or worsening cough, difficulty breathing, and fever. Your doctor may need to stop treatment to treat these problems.
This medicine may increase the risk of severe blood clots in the veins of the lower legs or lungs. These blood clots can move to other parts of the body, such as the lungs or brain. Tell your doctor immediately if you have chest pain, shortness of breath or swelling, pain, redness, or increasing temperature in your arm or leg.
Chronic intestinal inflammation and/or blockage in the intestine
Contact a doctor if you have stomach pain and cannot empty your bowels, especially if you also have a swollen stomach and loss of appetite.
Radiation therapy
If you have recently received radiation treatment to the pelvic or abdominal area, you may be at increased risk for bone marrow suppression. Talk to your doctor before starting treatment with Irinotecan Fresenius Kabi.
Renal function
Impaired renal function has been reported.
Heart disease
Tell your doctor if you have or have had a heart condition or if you have been given cancer medicines before. Your doctor will monitor you closely and discuss how the risk factors (eg smoking, high blood pressure, high cholesterol levels) can be reduced.
Vascular diseases
Irinotecan Fresenius Kabi has in rare cases been associated with blood circulation problems (blood clots in the blood vessels in the legs and lungs) and this can in rare cases occur in patients with several risk factors.
Other
This medicine can cause sores in the mouth and lips, often within the first few weeks after starting treatment. This can cause pain in the mouth, bleeding, and even difficulty eating. Your doctor or nurse can advise you on how to alleviate this, e.g. by changing the way you eat or brush your teeth. If necessary, your doctor may prescribe painkillers.
Tell your doctor or dentist that you are receiving this medicine if an operation or other procedure is planned.
If this medicine is used with other cancer medicines, be sure to read the package leaflet for these medicines as well.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Other medicines and Irinotecan Fresenius Kabi
Irinotecan Fresenius Kabi may interact with a variety of medicines and supplements that may either increase or decrease the level of medicines in your blood. Tell your doctor or pharmacist if you are taking, have recently taken, or might take the following:
- drugs for the treatment of seizures (carbamazepine, phenobarbital, phenytoin and phosphenytoin)
- medicines used to treat fungal infections ( ketoconazole , itraconazole, voriconazole and posaconazole)
- drugs for the treatment of bacterial infections (clarithromycin, erythromycin and telithromycin)
- drugs for the treatment of tuberculosis (rifampicin and rifabutin)
- St. John’s wort (a (traditional) herbal medicine)
- live, attenuated vaccines
- drugs for the treatment of HIV (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir and others)
- drugs used to suppress the body’s immune system to prevent rejection after organ transplantation (cyclosporine and tacrolimus)
- cancer drugs (regorafenib, crizotinib, idelalisib and apalutamide)
- Vitamin K inhibitors (common blood thinners, such as warfarin )
- muscle relaxants in connection with general anesthesia and surgery (suxamethonium)
- 5-fluorouracil / folic acid
- bevacizumab (inhibits blood vessel growth)
- cetuximab ( epidermal growth factor receptor blocker ).
Tell your doctor, pharmacist, or nurse before receiving Irinotecan Fresenius Kabi if you are already receiving or have recently received chemotherapy (or radiation therapy).
Do not start or stop taking any medicine while you are being treated with Irinotecan Fresenius Kabi without first talking to your doctor.
This medicine can cause severe diarrhea. Try to avoid laxatives and agents that make the stool softer while you are taking this medicine.
There may be additional medicines that affect or are affected by Irinotecan Fresenius Kabi. Check with your doctor, pharmacist, or nurse for other medicines, (traditional) herbal medicines, and supplements you are using. Also, check if alcohol can cause problems with this medicine.
Pregnancy, breastfeeding and fertility
Women of childbearing potential and men should use effective contraception during treatment and 1 month (women) and 3 months (men) after stopping treatment.
Pregnancy
This medicine can cause birth defects if taken at conception or during pregnancy. Men and women taking this medicine should use a reliable contraceptive during treatment. It is important to check with your doctor what types of contraceptives can be used with this medicine. This medicine should be used in pregnant women 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.
Breast-feeding
No studies have been performed. This medicine may pass into breast milk and affect the baby. Breast-feeding should be discontinued during treatment with this medicine.
If you are breastfeeding, talk to your doctor or pharmacist before taking this medicine.
Fertility
No studies have been performed. This medicine may affect your fertility. Talk to your doctor about the possible risk and what options you have for preserving your ability to have children.
Driving and using machines
During the first 24 hours after receiving this medicine, you may experience dizziness and/or visual disturbances. If you get this side effect, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance.
Irinotecan Fresenius Kabi contains sorbitol and sodium
This medicine contains 45 mg of sorbitol in each ml of concentrate. Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance, a rare, inherited disease, you (or your child) should not use this medicine. Patients with hereditary fructose intolerance cannot break down fructose, which can cause serious side effects.
Talk to your doctor before using this medicine if you (or your child) have hereditary fructose intolerance, or if your child can no longer eat sweet food or drink without feeling sick, vomiting, or feeling uncomfortable such as bloating stomach cramps, or diarrhea.
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free. is next to “sodium-free”.
How to use Irinotecan Fresenius Kabi
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Irinotecan Fresenius Kabi will be given to you by a healthcare professional.
Your doctor may recommend a DNA test before giving the first dose of Irinotecan Fresenius Kabi.
Some people are genetically more prone to certain side effects of this drug.
The amount of Irinotecan Fresenius Kabi you receive depends on many different factors, such as your height and weight, your general condition or other health problems, and the type of cancer or condition being treated. The doctor determines the dose and the treatment schedule.
Irinotecan Fresenius Kabi will be given as an injection into a vein. You will receive an injection at a clinic or hospital. Irinotecan Fresenius Kabi must be given slowly, infusion one can take up to 90 minutes.
You can get other medicines to prevent nausea, vomiting, diarrhea, and other side effects when you get Irinotecan Fresenius Kabi. You may need to continue using these medicines for at least one day after injecting one with Irinotecan Fresenius Kabi.
Tell your healthcare provider if you experience burning sensation, pain, or swelling around the needle when you receive Irinotecan Fresenius Kabi. If drugs end up outside the vein, they can cause tissue damage. If you experience pain or notice redness or swelling at the infusion site when you receive Irinotecan Fresenius Kabi, tell your healthcare provider immediately.
There are currently several different recommended treatment regimens for Irinotecan Fresenius Kabi. It is usually given at three-week intervals (Irinotecan Fresenius Kabi treatment alone) or at two-week intervals (Irinotecan Fresenius Kabi is given in combination with 5-fluorouracil / folic acid). The dose depends on several different factors, such as the treatment schedule, your body size, your age and general condition, your blood counts and how well your liver is functioning, and if you have previously had radiation treatment of the pelvic/abdominal area and if you have side effects, such as diarrhea.
Only the doctor can assess the length of treatment.
If you use more Irinotekan Fresenius Kabi than you should
Seek medical attention immediately. Symptoms of overdose may include some of the serious side effects mentioned in this leaflet.
If you forget to take a dose of Irinotecan Fresenius Kabi
Contact your doctor if you miss a treatment with Irinotecan Fresenius Kabi.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. You must contact your doctor immediately if you get the following serious side effects (see section 2).
Seek the nearest emergency department if you have any of these signs of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, tongue, or throat.
- diarrhea (see section 2).
- Early diarrhea: Occurs within 24 hours of receiving this medicine. Symptoms include runny nose, increased saliva production, tear production in the eyes, sweating, redness and stomach cramps. (This may occur while you are receiving an infusion . If this happens, tell your healthcare provider immediately. You may be given medicines that prevent and / or alleviate this early side effect ).
- Late diarrhea: Occurs later than 24 hours after receiving this medicine. Due to the risk of dehydration and electrolyte disturbances in connection with diarrhea, it is important to be in contact with the healthcare staff for follow-up and advice regarding changes in medication and diet.
Talk to your doctor or nurse if you get any of the following side effects.
| Symptoms | Frequency * atmonotherapy | Frequency † atcombination therapy |
| The abnormally low number of white blood cells can cause an increased risk of infection | Very common | Very common |
| The low number of red blood cells that cause fatigue and shortness of breath | Very common | Very common |
| Decreased appetite | Very common | Very common |
| Cholinergic syndrome (see “Warnings and Precautions”) | Very common | Very common |
| Vomiting | Very common | Very common |
| Nausea | Very common | Very common |
| Abdominal pain | Very common | Usual |
| Hair loss (reversible) | Very common | Very common |
| Inflammation of the mucous membranes | Very common | Very common |
| Fever | Very common | Usual |
| The feeling of weakness and powerlessness | Very common | Very common |
| Low platelet count( blood cells that help the blood to clot) can cause bruising and bleeding | Usual | Very common |
| Abnormal liver values | Usual | Very common |
| Infection | Usual | Usual |
| Low white blood cell count with fever | Usual | Usual |
| Difficulty emptying the bowel | Usual | Usual |
| Abnormal kidney function values | Usual | Has not been reported |
* Very common: may affect more than 1 user in 10
† Common: may affect up to 1 in 10 users
No known frequency (can not be calculated from the available data)
- Severe, persistent or bloody diarrhea (which may be associated with stomach pain or fever) caused by a bacterium ( Clostridium difficile )
- Blood infection
- Dehydration (due to diarrhea and vomiting)
- Dizziness, rapid heartbeat and pale skin ( hypovolemia )
- Allergic reaction
- Temporary speech disorders during treatment or immediately after it
- Knitting
- High blood pressure (during or after infusion one)
- Heart problems *
- Pulmonary disease causing rash and shortness of breath (see section 2).
- Hiccup
- Stop in the gut
- Enlarged colon
- Bleeding in the intestine
- Inflammation of the colon
- Abnormal laboratory values
- Holes in the intestine
- Fatty liver
- Skin reactions
- Injection site reactions
- Low levels of potassium in the blood
- Low levels of salts in the blood, mainly in connection with diarrhea and vomiting
- Muscle cramps
- Kidney problems *
- Low blood pressure*
- Fungal infections
- Viral infections.
* In rare cases, these have been observed in patients who have had episodes of dehydration associated with diarrhea and/or vomiting or blood infections.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Irinotecan Fresenius Kabi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Before opening
Store in the original package. Sensitive to light.
After opening
The product should be diluted and used immediately after opening.
After dilution
Chemical and physical in-use durability after preparation/dilution has been demonstrated for 24 hours at 25 ° C or 48 hours at 2-8 ° C.
From a microbiological point of view, the solution should be used immediately after reconstitution . If the solution is not used immediately, the storage times and conditions are the responsibility of the user, and should not normally exceed 24 hours in 2-8 ºC, unless the preparation/dilution has been carried out under controlled and validated aseptic conditions.
Do not use this medicine if the solution is not clear and particle-free, or if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
What Irinotecan Fresenius Kabi contains
- The active substance is irinotecan hydrochloride trihydrate. The concentrate for solution for infusion contains 20 mg irinotecan hydrochloride trihydrate per ml, equivalent to 17.33 mg irinotecan per ml.
- One vial of 2 ml contains 40 mg irinotecan hydrochloride trihydrate.
- One vial of 5 ml contains 100 mg irinotecan hydrochloride trihydrate.
- A vial with 15 ml contains 300 mg irinotecan hydrochloride.
- A vial with 25 ml contains 500 mg irinotecan hydrochloride.
- Other ingredients (excipients) are: sorbitol (E420), lactic acid (E270), sodium hydroxide (E524) and water for injections.
What the medicine looks like and contents of the pack
Irinotecan Fresenius Kabi is a clear solution with a bright yellow color.
Irinotecan Fresenius Kabi 20 mg / ml concentrate for solution for infusion is a clear, colorless to light yellow solution, free from visible particles and packaged in a yellow glass vial.
The product is available as individually packaged vials containing either 40 mg / 2 ml, 100 mg / 5 ml, 300 mg / 15 ml or 500 mg / 25 ml. The vials are for single use only.
Not all packaging may be marketed.
Marketing Authorisation Holder
Fresenius Kabi AB
751 74 Uppsala
Manufacturer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany