25 mg / mL concentrate for infusion solution
pemetrexed (pemetrexed)
1. What Armisarte is and what it is used for
Armisarte is a medicine used to treat cancer. It contains the active substance pemetrexed. Pemetrexed belongs to a group of medicines called folic acid analogs and disrupts processes that are necessary for the cells to divide.
Armisarte is given together with cisplatin, another anti-cancer drug, for the treatment of malignant pleural mesothelioma, a form of lung sac cancer, in patients who have not previously received anti-cancer drug therapy.
Armisarte is also used with cisplatin in the initial treatment of advanced lung cancer.
Armisarte can be prescribed to you if you have advanced lung cancer and your disease has responded to treatment or if it is largely unchanged after initial drug treatment.
In addition, Armisarte is used to treat advanced lung cancer whose disease has progressed, after other previous drug treatments have been used.
2. What you need to know before using Armisarte
Do not use Armisarte
- if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
- if you are breast-feeding. You should stop breast-feeding during treatment with Armisarte.
- if you have recently been vaccinated or are just about to be vaccinated against yellow fever.
Warnings and cautions
Talk to your doctor or pharmacist before receiving Armisarte.
Talk to your doctor or pharmacist if you have or have had kidney problems, as you may not be able to get Armisarte.
Before each infusion, blood samples will be taken to determine if the function of the kidneys and liver is sufficient and to check that the amount of blood cells is sufficient to obtain Armisarte. Your doctor may choose to change the dose or postpone your treatment depending on your general condition and if your blood levels are too low.
If you are also taking cisplatin, your doctor will make sure that you have been given enough fluids and that you will receive appropriate treatment before and after the cisplatin treatment to prevent vomiting.
If you have received radiation therapy or if such treatment is planned, tell your doctor, like radiation therapy and Armisarte may cause immediate or late side effects.
If you have recently been vaccinated, you should tell your doctor, as Armisarte may cause unwanted reactions in connection with the vaccination.
Tell your doctor if you have, or have previously had, heart disease.
If you have fluid accumulation around your lungs, your doctor may decide to remove the fluid before treatment with Armisarte.
Children and young people
There is no relevant use of Armisarte in the pediatric population.
Other medicines and Armisarte
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines for pain or inflammation (swelling), such as so-called non-steroidal anti-inflammatory drugs ( NSAIDs ), including over-the-counter medicines (such as ibuprofen ). There are many different types of these drugs with varying duration of action. Knowing the date of the planned infusion of Armisarte and/or renal function status, your doctor must advise you on which medicines you can take and when you can take them. If you are not sure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Like other chemotherapeutic drugs, Armisarte is not recommended in combination with live attenuated vaccines. Inactive vaccines should be used where possible.
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, tell your doctor and ask for advice before taking this medicine. Treatment with Armisarte should be avoided during pregnancy. Your doctor will discuss any possible risks when Armisarte is given during pregnancy. Women should use effective contraception during treatment with Armisarte.
Breast-feeding
Tell your doctor if you are breast-feeding.
Breast-feeding should be discontinued during treatment with Armisarte.
Fertility
Men are advised not to have children during and up to 6 months after Armisarte treatment and should therefore use an effective method of contraception during Armisarte treatment and up to 6 months after the end of treatment. If you plan to have children during treatment or the following 6 months after treatment, consult your doctor or pharmacist. You may want to seek advice on sperm preservation before starting treatment.
Driving and using machines
Treatment with Armisarte may make you feel tired. Be careful when driving or using machines.
3. How to use Armisarte
Armisarte 25 mg/ml concentrate for solution for infusion will always be given to you by a healthcare professional. Dose one of Armisarte is 500 mg per square meter of body surface area. Your height and weight are used to calculate the body surface area. Your doctor will use the measurement of your body surface area to calculate the right dose for you. This dose can be adjusted or the treatment can be postponed depending on blood levels and your general condition. A hospital pharmacist, nurse, or doctor will have mixed Armisarte concentrate with 5% glucose solution for injection before giving it to you.
Armisarte is always given as an infusion into a friend. Infusion one lasts for about 10 minutes.
When Armisarte is given in combination with cisplatin:
Your doctor or hospital pharmacist will have calculated the required dose using your height and weight. Cisplatin is also given as an infusion into a vein and is given about 30 minutes after the end of the Armisarte infusion. Infusion one of cisplatin lasts for about 2 hours.
You usually receive an infusion once every three weeks.
Other medicines:
Corticosteroids: Your doctor will prescribe steroid tablets (equivalent to 4 milligrams of dexamethasone twice daily). You should take these tablets the day before, on the day of treatment, and the day after treatment with Armisarte. The tablets are given to reduce the frequency and severity of the skin reactions that may occur during treatment for cancer.
Vitamin supplement: Your doctor will prescribe a preparation of folic acid ( vitamin ) to be taken by mouth or a multivitamin preparation containing folic acid (350 to 1000 micrograms) that you should take once a day during treatment with Armisarte. You should take at least 5 doses during the seven days preceding the first dose of one of Armisarte. You should continue to take folic acid for 21 days after the last Armisarte dose. You will also receive a vitamin B 12 – Injection (1000 micrograms) in the week before Armisarte – infusion done and then approximately every 9 weeks (equivalent to 3 treatment regimens with Armisarte). Vitamin B 12 and folic acid are given to reduce the possible harmful effects of cancer treatment.
Your condition will be closely monitored during treatment. This involves routine blood tests, including checks on your liver and kidney function. Your dose may change or treatment may be delayed depending on the results of these tests.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should contact your doctor immediately if you notice any of the following side effects:
- Fever or infection (common): if you have a temperature of 38º C or more, sweating, or other signs of an infection (because you may have a lower than normal white blood cell count, which is very common). Infection one (blood poisoning) can be serious and lead to death.
- If you start to feel chest pain (common) or have a fast heart rate (less common).
- If you feel pain, redness, swelling, or soreness in your mouth (very common).
- Allergic reaction: if you get a rash (very common) / burning or stinging sensation (common) or fever (common). Skin reactions can be severe and lead to death (rare). Contact your doctor if you get a lot of rash, itching, or blisters ( Stevens-Johnson syndrome or toxic epidermal necrolysis ).
- If you get tired, feel weak, get short of breath easily, or if you look pale (because you may have less hemoglobin than normal, which is very common).
- If it bleeds from the gums, nose, or mouth or you get any non-stop bleeding, reddish or pinkish urine, unexpected bruising (because you may have fewer platelets than normal, which is very common).
- If you experience sudden shortness of breath, intense chest pain, or cough with bloody cough (less common) (may indicate a blockage in the blood vessels of the lungs)
Other side effects of Armisarte that may occur:
Very common (may affect more than 1 user in 10) :
- Decreased white blood cell count
- Low hemoglobin ( anemia )
- Reduced platelet count
- Diarrhea
- Vomiting
- Pain, redness, swelling, or soreness in the mouth
- Nausea
- Decreased appetite
- Fatigue (fatigue)
- Skin rash, scaly skin
- Hair loss
- Constipation
- Loss of feeling
- Kidneys: abnormal blood counts
Common (may affect up to 1 in 10 people):
- Allergic reaction: skin rash/burning or stinging sensation
- Infection (including sepsis)
- Fever
- Dehydration
- Kidney failure
- Skin irritation and itching
- Hives
- Chest pain
- Muscle weakness
- Conjunctivitis (inflamed eye)
- Troubled stomach
- Abdominal pain
- Taste changes
- Liver: abnormal blood counts
- Tear-filled eyes
- Dizziness
Uncommon (may affect up to 1 in 100 people):
- Acute renal failure
- Fast or irregular heart rate
- Inflammation of the esophageal mucosa (esophagus) has occurred with pemetrexed and radiation therapy
- Colitis ( inflammation of the colon wall, which may be accompanied by bleeding from the intestines)
- Interstitial pneumonitis (scarring of the lungs)
- Edema (accumulation of fluid in any body tissue that causes swelling)
- Some patients have had a heart attack, stroke, or ‘mini-stroke’ during treatment with pemetrexed, usually in combination with other cancer treatments.
- Pancytopenia – combined low number of white blood cells, red blood cells, and platelets
- Radiation pneumonitis (scarring of the air bubbles in connection with radiation therapy) may occur in patients who have also received radiation therapy either before, during, or after treatment with pemetrexed.
- Pain and low temperature in arms or legs with discoloration have been reported.
- Blood clots in the pulmonary blood vessels ( pulmonary embolism )
Rare (may affect up to 1 in 1,000 people):
- Skin rash, which looks like severe sun damage, can occur on skin that has previously (several days or years ago) been exposed to radiation treatment.
- Bullous conditions (skin diseases with blistering) including Stevens-Johnson syndrome and toxic epidermal necrolysis
- Immune-mediated hemolytic anemia (destruction of red blood cells caused by antibodies )
- Hepatitis (inflammation of the liver)
- Anaphylactic shock (severe allergic reaction )
Has been reported (occurs in an unknown number of users)
- Swelling of the legs with pain and redness
- Increased urine output
- Thirst and increased water intake
- Hypernatremia – increased sodium content in the blood
You may get any of these symptoms and/or ailments. If you start to experience any of these side effects, talk to your doctor as soon as possible.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Armisarte
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 label and carton after “EXP”. The expiration date is the last day of the specified month.
Store and transport cold (2 ° C – 8 ° C).
Do not freeze.
Keep the vial in the outer carton. Sensitive to light.
Infusion solution: Chemical and physical shelf life at room temperature for 3 days and in a refrigerator for 21 days has been demonstrated for pemetrexed infusion solution. From a microbiological perspective, the product should be used directly. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. This storage should not be longer than 24 hours at 2 ºC – 8 ºC unless dilution has been performed under controlled and validated aseptic conditions.
Armisarte should not be used if particles are observed.
This medicine is for single use only. Any unused solution should be disposed of in accordance with local requirements.
6. Contents of the packaging and other information
Content declaration
The active substance is pemetrexed.
1 ml of the concentrate contains 25 mg of pemetrexed (as pemetrexed diacid). Further dilution of healthcare professionals is required before injection.
One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid).
One vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diacid).
One vial of 34 ml concentrate contains 850 mg of pemetrexed (as pemetrexed diacid).
One vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid).
The other ingredients are trometamol (for pH adjustment), citric acid, anhydrous, methionine, water for injections
What the medicine looks like and the contents of the pack
Armisarte concentrate for solution for infusion (sterile concentrate) is a clear, colorless to the slightly yellowish solution or yellow-green solution.
Armisarte is supplied in a colorless vial with a rubber stopper and an aluminum seal with a polypropylene sheet. The vials may be enclosed in a protective sleeve.
Each pack of Armisarte contains one vial.
Pack sizes:
1 x 4 ml vial (100 mg / 4ml)
1 x 20 ml vial (500 mg / 20 ml)
1 x 34 ml vial (850 mg / 34 ml)
1 x 40 ml vial (1000 mg / 40 ml)
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Actavis Group PTC ehf.
Reykjavíkurvegur 76‑78
220 Hafnarfjörður
Iceland
Manufacturer:
PLIVA CROATIA Ltd.
10000 Zagreb
Prilaz baruna Filipovića 25
Croatia
Actavis Italy SpA
Viale Pasteur 10
20014 Nerviano (Milan)
Italy
SC Sindan-Pharma SRL
11 Ion Mihalache Blvd.
011171 Bucharest
Romania
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel / Tel: + 32 (0) 38 20 73 73 | LithuaniaUAB “Sicor Biotech”Tel: +370 5 266 0203 |
| BulgariaOctavis FADTel: +359 2 489 95 85 | Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AGTel / Tel: + 32 (0) 38 20 73 73 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel .: +36 1 288 6400 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaActavis Ltd.Tel: +35621693533 |
| Germanyratiopharm GmbHTel: +49 731 402 02 | The NetherlandsTeva Nederland BVTel: +31 (0) 800 0228 400 |
| EestiUAB “Sicor Biotech” Eesti subsidiaryTel: +372 661 0801 | NorwayTeva Norway ASTel: +47 66 77 55 90 |
| GreeceSpecify ABEE:Ηλ: +30 210 5401500 | Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 (0) 1 97007 0 |
| SpainTeva Pharma, SLUTel: + (34) 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z ooTel: +48 22 345 93 00 |
| FranceTeva HealthTel: + (33) 1 55 91 78 00 | PortugalTeva Pharma – Pharmaceutical Products LdaTel: +351 21 476 75 50 |
| CroatiaPliva Hrvatska dooTel: +385 1 37 20 000 | RomaniaTeva Pharmaceuticals SRLTel: +4021 230 65 24 |
| IrelandActavis Ireland LimitedTel: +353 (0) 21 4619040 | SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| IcelandActavis Group PTC ehf.Phone: +354 550 3300 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 2 57 26 79 11 |
| ItalyTeva Italia SrlTel: + (39) 028917981 | Finland / Finlandratiopharm OyPuh / Tel: +358 (0) 20 180 5900 |
| ΚύπροςSpecify ABEE:Ηλ: +30 210 5401500Greece | |
| LatviaUAB “Sicor Biotech” branch of LatviaTel: +371 673 23 666 | United KingdomActavis UK LimitedTel: +44 1271 385257 |