20 mg / ml concentrate for solution for infusion
Irinotecan hydrochloride trihydrate
What Irinotecan Accord is and what it is used for
Irinotecan Accord belongs to a group of medicines called cytostatics (medicines for cancer). Irinotecan Accord is used for treating advanced cancer of the colon and rectum in adults, either in combination with other medicines or alone. Irinotecan Accord 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.
Your doctor may use a combination of Irinotecan Accord and 5-fluorouracil / folic acid and bevacizumab to treat colon or rectal cancer.
Your doctor may use a combination of Irinotecan Accord and capecitabine with or without bevacizumab to treat colon and rectal cancer.
Your doctor may use a combination of Irinotecan Accord and cetuximab to treat a specific type of colon cancer (KRAS wild-type) that expresses a protein called EGFR.
Irinotecan hydrochloride trihydrate contained in Irinotecan Accord 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.
2. What you need to know before using Irinotecan Accord
Do not use Irinotecan Accord
- is allergic to Irinotecan Accord or any of the other ingredients of this medicine (listed in section 6)
- have or have had chronic inflammatory bowel disease or had bowel obstruction (intestinal obstruction)
- ammar
- have severe liver disease
- has severe bone marrow effects
- has a severely impaired general status (evaluated using an international standard, general status / Performance Status (PS) higher than 2 on the WHO scale)
- uses the herbal medicine St. John’s wort ( Hypericum perforatum )
- should receive or have recently received live, attenuated vaccines (yellow fever vaccine, chickenpox, shingles , measles, mumps, rubella, tuberculosis , rotavirus, influenza ) and not for 6 months after stopping chemotherapy .
If you are receiving Irinotecan Accord in combination with other medicines, be sure to read the package leaflet for these medicines as well, as they may not be suitable for you.
Warnings and cautions
Particular caution should be exercised when administering this medicinal product to elderly patients.
Because Irinotecan Accord is an anti-cancer drug, it will be given in a special ward under the supervision of a doctor who is trained in the use of anti-cancer drugs. The ward staff will explain what you need to think about during and after the treatment. This leaflet will help you remember this.
Before you are treated with Irinotecan Accord, tell your doctor if any of the following apply to you:
- you have liver problems or jaundice
- you have kidney problems
- you have asthma
- you have ever received radiation therapy
- you have previously experienced severe diarrhea or fever after treatment with Irinotecan Accord.
- you have heart problems
- you smoke, have high blood pressure or high cholesterol because it may increase the risk of heart problems during treatment with Irinotecan Accord
- you have received or will receive vaccinations
- you are taking other medicines; see section “ Other medicines and Irinotecan Accord ” below.
1) The first 24 hours after administration of Irinotecan Accord
While Irinotecan Accord is being given (30-90 minutes) and shortly thereafter, you may experience some of the following symptoms:
- diarrhea
- increased tear flow
- sweating
- visual disturbance
- abdominal pain
- increased amount of saliva in the mouth
Acute cholinergic syndrome
This drug can affect the part of the nervous system that controls body excretion, which can lead to so-called cholinergic syndrome. Symptoms may include 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 that can help keep them under control.
2) From the day after treatment with Irinotecan Accord until the next treatment
During this period, you may experience various types of symptoms, which can be severe and require immediate treatment and close monitoring.
Diarrhea
If you get diarrhea after more than 24 hours after receiving Irinotecan Accord (“delayed diarrhea”), it may be severe. Diarrhea usually occurs about 5 days after you receive the medicine. Diarrhea should be treated immediately and closely monitored. If left untreated, it can lead to dehydration and severe chemical imbalance 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 that you have it at home when you need it. Do the following immediately after the first loose stool:
- Take the treatment for diarrhea that your doctor has given you, exactly according to your doctor’s instructions. This treatment should not be changed without consulting a doctor. The recommended treatment for diarrhea is loperamide (4 mg as a first dose and then 2 mg every two hours, also overnight). This treatment should be continued for at least 12 hours after the last loose stool. The recommended dose of loperamide should not be taken for more than 48 hours.
- Immediately drink large amounts of water and liquid substitutes (eg water, soda, carbonated beverage, soup or liquid substitute).
- Immediately inform the doctor responsible for treatment of the diarrhea. If you can not reach the doctor, contact the hospital ward where you are receiving Irinotecan Accord. It is very important that they know about the diarrhea.
You must immediately inform the doctor or ward treating you of:
- you are nauseous, have vomiting or fever and diarrhea
- you still have diarrhea 48 hours after starting treatment for diarrhea
Note! Do not take any other treatment for diarrhea than the one you have received from your doctor and the fluids mentioned above. Follow your doctor’s instructions. Treatment for diarrhea should not be used to prevent new diarrhea attacks even if you have had delayed diarrhea during previous treatment cycles.
Fever
If the body temperature rises above 38 ° C, it can be a sign of infection , especially if you also have diarrhea. Contact your doctor or ward immediately if you have a fever (above 38 ° C) so that they can give you the necessary treatment.
Nausea and vomiting
If you are nauseous and / or have vomiting, contact your doctor or ward immediately. Before receiving treatment, your doctor may give you medicines to prevent 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.
Neutropenia
Irinotecan Accord may cause a decrease in the number of certain white blood cells , which play an important role in fighting infection . This is called neutropenia . Neutropenia often occurs during treatment with Irinotecan Accord and returns after the end of treatment. Doctors should prescribe regular blood tests so that the number of white blood cells can be monitored. Neutropenia is serious and should be treated immediately and closely monitored. Tell your doctor or nurse immediately if you get any signs of infection, such as fever (38 ° C or higher), chills, pain when urinating, new onset of 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 the 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 get unusual bruising or bleeding such as nosebleeds, bleeding gums when brushing your teeth or black, tar-like stools.
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 deal with 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 experience chest pain, shortness of breath or swelling, pain, redness or heat in an 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.
S trawl treatment
If you have recently received radiation treatment to the pelvic or abdominal area, you may be at increased risk of developing bone marrow suppression. Talk to your doctor before starting treatment with Irinotecan Accord.
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 been given cancer medicines before. Your doctor will monitor you closely and discuss how risk factors (eg smoking, high blood pressure , high cholesterol) can be reduced.
Vascular diseases
Irinotecan Accord has in rare cases been associated with problems with the blood circulation (blood clots in the blood vessels in the legs and lungs) and this can in rare cases occur in patients with several risk factors.
Hepatic impairment
Before starting treatment with Irinotecan Accord and before each new treatment cycle, liver function should be checked (through blood tests).
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 medication to relieve the pain.
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 leaflets 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 Accord
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal remedies, vitamins and minerals.
- Medicines for the treatment of seizures (carbamazepine, phenobarbital, phenytoin and phosphenytoin)
- Medicines for the treatment of fungal infections ( ketoconazole , itraconazole, voriconazole and posaconazole)
- Medicines for the treatment of bacterial infections (clarithromycin, erythromycin and telithromycin)
- Medicines for the treatment of tuberculosis (rifampicin and rifabutin)
- St. John’s wort (a (traditional) herbal medicine)
- Live, attenuated vaccines
- Medicines for the treatment of HIV (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir and others)
- Drugs used to lower 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 anesthesia and surgery (suxamethonium)
- 5 ‑ fluorouracil / folic acid
- Bevacizumab (inhibits blood vessel growth)
- Cetuximab (blockers of epidermal growth factor receptor)
Tell your doctor, pharmacist or nurse before receiving Irinotecan Accord if you are already receiving or have recently received chemotherapy (or radiation therapy).
If you need to have an operation, tell your doctor or anesthetist that you are being treated with irinotecan, as it may change the effect of certain medicines used during the operation.
Do not start or stop taking any medicine while you are being treated with Irinotecan Accord 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 Accord. Check with your doctor, pharmacist or nurse regarding other medicines, (traditional) herbal medicines and supplements you are using, and whether alcohol can cause problems with this medicine.
Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Irinotecan Accord must not be used during pregnancy. Irinotecan Accord may cause malformations. This medicine should only be used in pregnant women if the potential benefit to the mother outweighs the risk to the fetus.
Fertile women should avoid getting pregnant. Both male and female patients should use contraception during treatment and for at least three months (for men) and one month (for women) after treatment. If you become pregnant during this period, you must inform your doctor immediately.
Breast-feeding
No studies have been performed. This medicine may pass into breast milk and affect the baby. Breast-feeding must be discontinued during treatment with Irinotecan Accord. Consult a doctor before taking any medicine.
Fertility
No studies have been performed. This medicine may affect your fertility . Talk to your doctor about the possible risks of this medicine and what your options are for preserving your chances of having children.
Driving and using machines
In some cases, Irinotecan Accord may cause side effects that affect the ability to drive and use machines.
During the first 24 hours after receiving Irinotecan Accord, you may feel dizzy or have visual disturbances. If this happens, do not drive or use any tools or 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. Discuss with your doctor if you are unsure.
Irinotecan Accord contains excipients
This medicine contains 45 mg sorbitol per ml. 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 per dose , ie essentially ‘ sodium – free’ . is next to “sodium-free”.
3. How to use Irinotecan Accord
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Irinotecan Accord will be given to you by healthcare professionals.
Your doctor may recommend a DNA test before the first dose of Irinotecan Accord.
Some people are genetically more likely to get certain side effects from this drug.
You may be given other medicines to prevent nausea, vomiting, diarrhea and other side effects when you receive Irinotecan Accord. You may need to continue using these medicines for at least one day after injecting one with Irinotecan Accord.
Tell your healthcare provider if you experience burning sensation, pain or swelling around the infusion needle when you receive Irinotecan Accord. If drugs end up outside the vein, it can cause tissue damage. If you experience pain or notice redness or swelling at the infusion site when you receive Irinotecan Accord, inform your healthcare professional immediately.
Irinotecan Accord will be given as an infusion (drip) into a vein over a period of 30 to 90 minutes. The amount of infusion given to you depends on your age, size and your general medical condition. It also depends on any other treatment you may have received for your cancer. The doctor calculates your body area in square meters (m 2 ).
- If you have previously been treated with 5-fluorouracil, you will usually be treated with Irinotecan Accord alone and start with a dose of 350 mg / m 2 once every three weeks.
- If you have not received chemotherapy before, you will normally receive 180 mg / m 2 Irinotecan Accord once every two weeks. This will then be followed by folic acid and 5-fluorouracil.
- If you are being treated with irinotecan in combination with cetuximab, you will normally receive the same dose of irinotecan given in the last previous treatment cycles that contained irinotecan. Irinotecan Accord must not be given earlier than 1 hour after the end of the infusion of cetuximab.
The doses can be adjusted by your doctor depending on your general condition and any side effects .
If you use more Irinotecan Accord than you should
It is unlikely that you will get too much Irinotecan Accord. Should this still happen, you can get severe blood diseases and diarrhea. Maximum supportive care should be taken to prevent dehydration due to diarrhea and to treat any infectious complications. Talk to the doctor who gives you the medicine.
If you forget to use Irinotecan Accord
It is very important that you get all the planned doses . If you miss a dose , contact your doctor immediately.
4. Possible side effects
Like all medicines, Irinotecan Accord can cause side effects , although not everybody gets them. Your doctor will inform you about these side effects and explain the risks and benefits of treatment. Some of these side effects need to be treated immediately.
See also the information in the section “Warnings and precautions” .
If you get any of the following side effects after taking this medicine, contact your doctor immediately. If you are not in the hospital, you MUST SEEK a hospital immediately.
- Allergic reactions. If you have wheezing, difficulty breathing, swelling, rash or itching (especially if your whole body is affected), contact a doctor or nurse immediately.
- Severe allergic reactions (anaphylactic / anaphylactoid reactions) can occur, usually minutes after injection of the drug: rash including red, itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may lead to difficulty swallowing) and it may feel like you are about to faint.
- Diarrhea (see section 2).
- Early diarrhea: Occurs within 24 hours of receiving this medicine, accompanied by symptoms such as runny nose, increased salivation, watery 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.
Very common (may affect more than 1 user in 10)
- blood disease: neutropenia (decreased number of certain white blood cells ), thrombocytopenia (decreased number of platelets ), anemia (decreased number of red blood cells )
- delayed diarrhea
- nausea and vomiting
- hair loss (hair grows back after treatment)
- transient increase in liver enzymes or bilirubin during combination therapy.
Common (may affect up to 1 in 10 people)
- acute cholinergic syndrome: the main symptoms consist of diarrhea and other symptoms such as abdominal pain; red, sore, itchy or watery eyes ( conjunctivitis ); rinnsnuva ( rhinitis ); low blood pressure; dilation of blood vessels; sweating; overindulge; general malaise and nausea; dizziness, visual disturbances; small pupils; watery eyes and increased salivation, occurring during or within 24 hours after infusion with Irinotecan Accord
- fever, infection (including sepsis)
- fever associated with a sharp decrease in white blood cells
- dehydration, usually associated with diarrhea and / or vomiting
- constipation
- fatigue
- elevated liver enzyme levels and creatinine levels in the blood.
Uncommon (may affect up to 1 in 100 people)
- allergic reactions: if you have wheezing, difficulty breathing, swelling, rash or itching (especially if your whole body is affected), contact a doctor or nurse immediately
- mild skin reactions; mild reactions at the infusion site
- breathing difficulties
- lung disease (interstitial lung disease)
- stop in the intestine
- abdominal pain and inflammation leading to diarrhea (a condition called pseudomembranous colitis )
- Rare cases of renal failure , hypotension and cardiac ‑ circulatory failure have been observed in patients suffering from dehydration associated with diarrhea and / or vomiting or blood poisoning.
Rare (may affect up to 1 in 1,000 people)
- severe allergic reactions (anaphylactic / anaphylactoid reactions) may occur, usually minutes after injection of the drug: rash including red, itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may lead to difficulty swallowing) and it may feel like you are about to faint. If this happens, consult a doctor immediately
- early effects such as muscle contraction or cramping and numbness ( paresthesia )
- bleeding in the gastrointestinal tract and inflammation of the colon including the appendix
- intestinal perforation (hole in the intestinal wall), loss of appetite, abdominal pain, mucositis
- pancreatitis
- high blood pressure during and after the medicine is given
- decreased levels of potassium or sodium in the blood, often associated with diarrhea and vomiting.
Very rare (may affect up to 1 in 10,000 people)
- transient speech disorders
- elevated levels of certain digestive enzymes, which break down sugar and fats.
Has been reported (may occur in an unknown number of users):
- severe, persistent or bloody diarrhea (which may be associated with abdominal pain or fever) caused by bacteria called Clostridium difficile
- blood infection
- dehydration (due to diarrhea and vomiting)
- dizziness, rapid heartbeat and pale skin (a condition called hypovolemia )
- allergic reaction
- temporary speech disorders during or shortly after treatment
- tingling and numbness
- high blood pressure (during or after infusion )
- heart problems *
- lung disease that causes wheezing and shortness of breath (see section 2)
- hiccup
- intestinal blockage
- enlarged colon
- bleeding from the intestines
- inflammation of the colon
- deviating laboratory results
- holes in the intestine
- fatty liver disease
- skin reactions
- reactions at the site where the drug was administered
- low levels of potassium in the blood
- low levels of salt in the blood that are usually associated with diarrhea and vomiting
- muscle cramps
- kidney problems *
- low blood pressure*
- fungal infections
- viral infections
* Rare cases of these events have been observed in patients who have experienced dehydration associated with diarrhea and / or vomiting or infection in the blood.
If you receive Irinotecan Accord in combination with cetuximab , some of the side effects you may experience may also be related to this combination. Such side effects may include: acne-like rash. Thus, you must also read the package leaflet for cetuximab.
If you receive Irinotecan Accord in combination with capecitabine , some of the side effects you may experience may also be related to this combination. Such side effects may include: very common: blood clots, common: allergic reactions, heart attack and fever in patients with low white blood cell count . You must therefore also read the package leaflet for capecitabine.
If you are receiving Irinotecan Accord in combination with capecitabine and bevacizumab , some of the side effects you are experiencing may also be related to this combination. Such side effects may include: low white blood cell count , blood clots, high blood pressure and heart attack. You must therefore also read the package leaflet for capecitabine and bevacizumab.
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 Accord
Keep this medicine out of the sight and reach of children.
Do not freeze.
For single use only.
No special storage instructions. Store in the original package. Sensitive to light. Used before the expiry date which is stated on the carton and vial after EXP. The expiration date is the last day of the specified month.
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
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 40 mg irinotecan hydrochloride trihydrate.
- One 5 ml vial contains 100 mg irinotecan hydrochloride trihydrate.
- One 15 ml vial contains 300 mg irinotecan hydrochloride trihydrate.
- One 25 ml vial contains 500 mg irinotecan hydrochloride trihydrate.
- One 50 ml vial contains 1,000 mg of irinotecan hydrochloride trihydrate.
- The other ingredients are sorbitol (E420), lactic acid , sodium hydroxide, hydrochloric acid and water for injections.
What the medicine looks like and contents of the pack
Irinotecan Accord 20 mg / ml concentrate for solution for infusion is a clear, light yellow solution.
Pack sizes:
2 ml
5 ml
15 ml
25 ml
50 ml
Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow
Middlesex HA1 4HF
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands