20 mg / mL concentrate for infusion solution
What Irinotecan Actavis is and what it is used for
Irinotecan Actavis is a cancer medicine that contains the active substance irinotecan hydrochloride trihydrate. Irinotecan hydrochloride trihydrate prevents the growth and spread of cancer cells in the body.
Irinotecan Actavis is used in combination with other medicines to treat patients with advanced or metastatic colorectal cancer.
Irinotecan Actavis can be used alone ( monotherapy ) in patients with metastatic cancer of the colon or rectum whose disease has recurred or progressed after undergoing flurouracil-based treatment.
Irinotecan contained in Irinotecan Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Irinotecan Actavis
Do not use Irinotecan Actavis
- if you are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients of this medicine (listed in section 6).
- if you have chronic inflammatory bowel disease and / or intestinal obstruction (intestinal obstruction)
- if you are breast-feeding (see section 2)
- if you have elevated levels of bilirubin in your blood (more than 3 times the normal value)
- if you have severe bone marrow effects
- if you have a bad general condition (General Status / Performance Status (PS) higher than 2 on the WHO scale)
- if you are taking or have recently taken St. John’s wort (a (traditional) herbal medicine).
- if you are taking or have recently taken a live, attenuated vaccine (vaccine against yellow fever, chickenpox, shingles , measles, mumps, rubella, tuberculosis , rotavirus, influenza ). This also applies 6 months after the end of chemotherapy.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Irinotecan Actavis.
Take special care with Irinotecan Actavis. The use of Irinotecan Actavis should be restricted to departments specializing in chemotherapy and should only be administered under the supervision of a qualified physician.
Diarrhea
Irinotecan Actavis can cause diarrhea, which in some cases can be severe. Diarrhea may start a few hours or days after infusion of one of the drugs. If left untreated, it 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 right away so you have it at home when you need it.
- Take the medicine as prescribed at the first sign of loose or frequent stools.
- Drink large amounts of water and (or) salty drinks (mineral water, soft drinks or soup).
- Contact your doctor or nurse if you still have diarrhea, especially if it lasts more than 24 hours, or if you become dizzy or faint.
Neutropenia (decrease in certain white blood cells )
This medicine can reduce the number of white blood cells, mainly in the weeks after receiving the medicine. This may increase the risk of infection. Tell your doctor or nurse immediately if you get signs of infection such as fever (38 o C or higher), chills, pain when urinating, a new cough, or expectoration of mucus. Avoid being close to people who are sick or have an infection. Tell your doctor immediately if you get any signs of infection.
Blood tests
Your doctor will probably take blood samples before and during your treatment to check the effects of the treatment on different blood levels and blood cell levels. Based on the test results, you may need medication to treat these effects. Your doctor may also need to reduce or delay your next dose of irinotecan or stop treatment altogether. Be sure to go to all doctor visits and samples.
This drug can reduce your level of blood platelets ( thrombocytes ) weeks after you receive your drugs, which can increase the risk of bleeding. Talk to your doctor before taking medicines or supplements that may affect the body’s ability to stop bleeding, such as medicines containing acetylsalicylic acid, warfarin or vitamin E. Tell your doctor immediately if you get unusual bruising or bleeding such as nosebleeds, bleeding gums when you brush teeth or black, tar-like feces.
Nausea and vomiting
You may experience nausea and vomiting on the day you receive this medicine or the first few days thereafter. Your doctor may prescribe medication before your treatment to prevent nausea and vomiting. Your doctor will probably prescribe nausea medication that you can take at home. Have these medicines available when you need them. Contact your doctor if you are unable to swallow fluid by mouth due to nausea and vomiting.
Acute cholinergic syndrome
This drug can affect parts of the nervous system that affect body secretions which can lead to what is called a cholinergic syndrome. Symptoms may include runny nose, increased salivation, increased tear flow, sweating, redness, stomach cramps, and diarrhea. Tell your doctor or nurse immediately if you notice any of these symptoms, some medicines can help keep them under control.
Lung diseases
In rare cases, patients who have received this medicine have had severe lung problems. Tell your doctor immediately if you experience a new or worsening cough, difficulty breathing, and fever. Your doctor may need to stop your treatment to deal with this problem.
This medicine may increase the risk of blood clots in the blood vessels in the legs or lungs, which can move to other parts of the body such as the lungs or brain. Contact a doctor immediately if you feel chest pain, shortness of breath or swelling, pain, redness, or increased heat in an arm or leg.
Chronic intestinal inflammation and/or blockage in the intestine
Contact your doctor if you experience abdominal pain and constipation, especially if you also have a swollen stomach and lose appetite.
Radiation
If you have recently received treatment with pelvic or abdominal radiation, you may be at increased risk of developing bone marrow suppression. Contact your doctor before starting treatment with Irinotecan Actavis.
Renal function
Impaired renal function has been reported.
Heart disease
Tell your doctor if you have or have had heart disease or if you have previously been given medicines for cancer. Your doctor will monitor you closely and discuss with you how you can reduce risk factors (eg smoking, high blood pressure, and high fat intake).
Vascular diseases
Irinotecan Actavis has in rare cases been associated with vascular disease (blood clots in the blood vessels of the legs and lungs) and this may occur in patients with multiple 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, or even difficulty eating. Your doctor or nurse may suggest ways to reduce this, such as changing the way you eat or brush your teeth. If necessary, your doctor may prescribe medication to help with the pain.
Tell your doctor or dentist that you are using this medicine if you are planning an operation or other procedure.
If you are taking a combination with other anticancer medicines, be sure to read the package leaflet for each medicine.
Children
Irinotekan should not be used in children.
Other medicines and Irinotecan Actavis
Irinotecan Actavis may interact with a variety of medicines and supplements which may either increase or decrease the level of the medicine in your blood. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following:
- Drugs used to treat seizures (carbamazepine, phenobarbital, phenytoin and phosphenytoin)
- Medicines used to treat fungal infections ( ketoconazole , itraconazole, voriconazole and posaconazole)
- Drugs used to treat bacterial infection (clarithromycin, erythromycin and telithromycin)
- Drugs used to treat tuberculosis (rifampicin and rifabutin)
- St. John’s wort (a (traditional) herbal medicine)
- Live attenuated vaccines
- Drugs used to treat HIV (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, aatazanavir and others)
- Drugs used to inhibit the immune system to prevent rejection of transplanted organs (cyclosporine and tacrolimus)
- Vitamin K antagonist (blood-thinning drugs such as warfarin )
- Muscle relaxants used in general anesthesia and surgery (suxamethonone)
- 5-fluorouracil / folic acid
- Bevacizumab (an inhibitor of blood vessel growth)
- Cetuximab (an EGF receptor inhibitor)
- Drugs used to treat cancer (regorafenib, crizotinib, idelalisib and apalutamide)
Tell your doctor, pharmacist, or nurse before receiving Irinotecan Actavis 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 Actavis without talking to your doctor first.
This medicine can cause severe diarrhea. Try to avoid laxatives and bowel regulators while taking this medicine.
There may be more drugs that affect or are affected by Irinotekan Actavis. Check with your doctor, pharmacist, or nurse about other medicines, (traditional) herbal medicines, and supplements and whether alcohol can cause problems with this medicine.
Pregnancy, breastfeeding and fertility
Women of childbearing potential and men should use effective contraception during treatment and up to one month and 3 months after treatment.
Pregnancy
This medicine can cause problems in the fetus if taken at the time of conception or during pregnancy. Men and women taking this medicine should use reliable contraception during treatment. It is important to discuss with your doctor what types of contraceptives can be used with this medicine. In pregnant women, treatment with this medicine should only be used if the potential benefit to the mother outweighs the risk to the fetus.
If you are pregnant or breastfeeding, 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, but 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 but this drug may affect fertility. Talk to your doctor about the possible risks of this medicine and different options to preserve the possibility of having children.
Driving and using machines
You may notice dizziness and/or vision problems for the first 24 hours after taking this medicine. Do not drive or use machines if you experience this side effect.
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. If you are not sure, talk to your doctor or pharmacist.
Irinotecan Actavis contains sorbitol and sodium
This medicine contains 45 mg of sorbitol in each ml of concentrate. Sorbitol is a source of fructose. If you have hereditary fructose intolerance, a rare genetic disorder, you should not take this medicine. Patients with hereditary fructose intolerance cannot break down fructose, which can cause serious side effects.
You must tell your doctor before receiving this medicine if you have hereditary fructose intolerance.
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free. is next to “sodium-free”.
3. How to use Irinotecan Actavis
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Irinotecan Actavis will be given to you by healthcare professionals.
Your doctor may recommend a DNA test before the first dose of Irinotecan Actavis.
Some people are genetically more likely to get certain side effects from the drug.
The amount of Irinotecan Actavis you will receive depends on many factors including your height and weight, your general health or other health problems and the type of cancer or disease to be treated. Your doctor will determine the dose and dosing schedule.
Irinotecan Actavis is given intravenously (as a drip) in a clinic or hospital. Irinotecan Actavis must be given slowly and the intravenous infusion may take up to 90 minutes to complete.
You can be given other medicines to prevent nausea, vomiting, diarrhea, and other side effects while you are receiving Irinotecan Actavis. You may need to continue using these medicines for at least 24 hours after the infusion of Irinotecan Actavis.
Tell your healthcare provider if you feel burning, pain, or swelling around the infusion site when Irinotecan Actavis is given. If the drug gets next to the vein, it can cause tissue damage. Tell your healthcare provider immediately if you experience pain or redness or swelling at the infusion site when you receive Irinotecan Actavis.
There are currently several treatment regimens recommended for Irinotecan Actavis. It is usually given either once every three weeks (Irinotecan Actavis is given alone) or once every two weeks (Irinotecan Actavis is given in combination with 5-fluorouracil and folic acid). Dose one depends on several factors, including treatment schedule, body size, age and general condition, blood cell levels how well your liver is working, if you have had radiation in your abdomen/pelvis and if you have had any side effects such as diarrhea.
Only your doctor can assess the duration of treatment.
If you use more Irinotecan Actavis than you should
Seek immediate care. Symptoms of overdose may include some of the serious side effects mentioned in this leaflet.
If you forget to take Irinotecan Actavis
Contact your doctor if you miss a scheduled treatment with Irinotecan Actavis.
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 experience any of these serious side effects (see section 2).
Seek emergency care if you get any of the following 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 after infusion one, accompanied by symptoms such as runny nose, increased salivation, watery eyes, sweating, redness , abdominal cramps. (This may happen while you are getting an infusion . If this happens, tell your healthcare provider immediately. Medicines to stop and / or reduce this early side effect may be given.
- Late diarrhea: Occurs later than 24 hours after infusion of the drug. As diarrhea can lead to dehydration and imbalance in electrolytes , it is important to be in contact with healthcare professionals for monitoring and advice on medicines and food and drink.
Talk to your doctor or nurse if you experience any of the symptoms below
| Symptoms | F örekommande frequency * at monotherapy | F örekommande frequency ** in combination therapy |
| Abnormally low white blood cell count may increase your 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 section 2) | Very common | Very common |
| Vomiting | Very common | Very common |
| Nausea | Very common | Very common |
| Abdominal pain | Very common | Common |
| Hair loss (reversible) | Very common | Very common |
| Inflammation of the mucous membranes | Very common | Very common |
| Fever | Very common | Common |
| Feels weak and has no energy | Very common | Very common |
| Low levels of platelets ( blood cells that help clot the blood), which can cause bruising or bleeding. | Common | Very common |
| Abnormal liver values | Common | Very common |
| Infection | Common | Common |
| Low levels of white blood cells with fever | Common | Common |
| Constipation | Common | Common |
| Abnormal kidney function values | Common | Not reported |
* Very common: may affect more than 1 user in 10
** Common: may affect up to 1 in 10 users
Has been reported: occurs in an unknown number of users
- Severe, persistent or bloody diarrhea (which may be associated with stomach pain or fever) caused by a bacterium called Clostridium difficile .
- Sepsis (blood poisoning)
- Dehydration (due to diarrhea and vomiting)
- Dizziness, palpitations and pale skin ( hypovolemia )
- Allergic reaction
- Transient speech difficulties during or shortly after treatment
- Tingling and ant crawling
- High blood pressure (during or after infusion )
- Heart problems *
- Lung disease that causes wheezing and shortness of breath (see section 2)
- Hiccup
- Constriction in the intestine
- Enlarged colon
- Intestinal bleeding
- Inflammation of the colon
- Abnormal results on blood tests
- Holes in the intestine
- Fatty liver
- Skin reactions
- Reactions at the site of administration
- Low levels of potassium in the blood
- Low levels of salts in the blood mainly linked to diarrhea and vomiting
- Muscle cramps
- Kidney problems *
- Low blood pressure*
- Fungal infections
- Viral infections
Isolated cases of these side effects have been observed in patients suffering from dehydration associated with diarrhea and/or vomiting or sepsis.
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 Actavis
Keep this medicine out of the sight and reach of children.
Do not freeze.
For single use only.
Store in original packaging. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
The product should be mixed and used immediately after opening.
If mixing is aseptic, the solution can be stored for up to 24 hours at 30 ° C and 48 hours at 2 ° C – 8 ° C (eg in a refrigerator).
6. Contents of the packaging and other information
Content declaration
- The active substance is irinotecan hydrochloride trihydrate.
- 1 ml of concentrate contains 20 mg irinotecan hydrochloride trihydrate equivalent to 17.33 mg irinotecan.
- One 2 ml vial contains 34.66 mg irinotecan as 40 mg irinotecan hydrochloride trihydrate.
- One 5 ml vial contains 86.65 mg irinotecan as 100 mg irinotecan hydrochloride trihydrate.
- One 15 ml vial contains 259.95 mg irinotecan as 300 mg irinotecan hydrochloride trihydrate.
- One 25 ml vial contains 433.25 mg irinotecan as 500 mg irinotecan hydrochloride trihydrate.
- The other ingredients are: sorbitol E420, lactic acid , sodium hydroxide and water for injection .
What the medicine looks like and contents of the pack
Irinotecan Actavis 20 mg/ml concentrate for solution for infusion is a clear, colorless to slightly yellow solution.
Pack sizes:
1 x 2 ml vial
1 x 5 ml vial
5 x 5 ml vial
1 x 15 ml vial
1 x 25 ml vial
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjörður
Iceland
Agent
Teva Sweden AB
Box 1070
251 10 Helsingborg
Manufacturer
SC SINDAN- PHARMA SRL
11 Ion Mihalache Blvd,
RO-011171 Bucharest
Romania
or
Actavis Italy SpA- Nerviano Plant
Viale Pasteur 10
20014 Nerviano (MI)
Italy