Pemtori IV 500 mg Solution

PEMTORI IV contains pemetrexed disodium, one of a group of medicines called cytostatic medicines, used in the treatment of cancer.

PEMTORI IV is used

• in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma
• in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer
• as treatment for patients with advanced stage lung cancer if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy
• as treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.

PEMTORI IV should not be administered:

• if you are hypersensitive (allergic) to pemetrexed disodium or any of the other ingredients of PEMTORI IV (see section 6)
• if you have recently received or are about to receive a vaccine against yellow fever

Warnings and precautions

Special care should be taken with PEMTORI IV if:

• you currently have or have previously had problems with your kidneys, as you may not be able to receive PEMTORI IV
• you are taking pain killers such as ibuprofen or aspirin as these medicines should be avoided for at least 2 days prior to, on the day of, and at least 2 days after administration of PEMTORI IV
• you are taking other pain medicine called NSAIDs as you should stop taking these medicines at least 5 days prior to, on the day of, and at least 2 days after PEMTORI IV administration
• if you have an accumulation of fluid around your lungs as your doctor may decide to remove the fluid before giving you PEMTORI IV
• if you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with pemetrexed
• if you have recently been vaccinated, as this may possibly cause a bad reaction with PEMTORI IV
• if you have a heart disease or history of heart problems
• if you are planning to have children as PEMTORI IV may cause irreversible infertility

Before each infusion your doctor will take a blood sample, to ensure that your kidneys and liver are functioning properly, and to check you have enough blood cells receive PEMTORI IV. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. If you are also receiving cisplatin, your doctor will make sure that you are property hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.

Children and adolescents

Do not give PEMTORI IV to children under the age of 18 years. PEMTORI IV has not been studied in children. There is no relevant use of PEMTORI in this population.

PEMTORI IV powder for solution for infusion will be reconstituted and diluted to the correct concentration by a healthcare professional. You will not be expected to give yourself PEMTORI IV. It will be given to you by a person who is qualified to do so.

PEMTORI IV will be given to you by intravenous infusion (injected into a vein) over a period of 10 minutes.

When using PEMTORI IV in combination with cisplatin:

Adults:

Cisplatin will also be given by infusion, approximately 30 minutes after the infusion with PEMTORI IV has finished. The infusion of cisplatin will last 2 hours. Your doctor will ensure that you are adequately hydrated (i.e. you drink a sufficient amount of water) both before and after treatment with cisplatin.

You should usually receive your infusion once every 3 weeks.

Additional medicines:

Corticosteroids: your doctor will prescribe you steroid tablets (equivalent to 4 mg of dexamethasone orally twice a day) that you will need to take the day before, the day of, and the day after PEMTORI IV treatment. This medicine should reduce the frequency and severity of any skin reactions that you may experience during your anticancer treatment.

Vitamin supplements: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1 000 mcg) which you must take once a day while you are receiving PEMTORI IV. You must take at least 5 doses a day during the seven days before the first dose of PEMTORI IV. You must continue to take the folic acid for 21 days after the last dose of PEMTORI IV. You will also receive an injection, into your muscle, of vitamin B12 (1000 mcg) in the week before administration of PEMTORI IV and then every 9 weeks after (corresponding to 3 courses of PEMTORI IV treatment). Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of the anti-cancer treatment.

Your doctor will tell you how long your treatment with PEMTORI IV will last.

If you have the impression that the effect of PEMTORI IV is too strong or too weak, tell your doctor or pharmacist.

If you are administered more PEMTORI IV than you should: Since a healthcare professional will administer PEMTORI IV, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdose.

If you forget to take/use PEMTORI IV: Since a healthcare professional will administer PEMTORI IV, it is unlikely that the dose will be missed.

PEMTORI IV can have side effects. Not all side effects reported for PEMTORI IV are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using PEMTORI IV, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using PEMTORI IV and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to PEMTORI IV. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Chest pain, abnormal heartbeat, heart attack.
• Pale, bluish discoloration, or darkening of the skin of the nose, ears, fingers, toes, or other surface areas (called peripheral ischemia). Extreme cases can lead to loss of fingers or toes or the need for limb amputation.
• Stevens-Johnson syndrome or other serious skin disorder (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters).
• Kidney failure - you may experience decreased urine output, swelling of the legs, ankles or feet, nausea or extreme tiredness, seizures or coma in severe cases.
• Signs of infection such as fever/chills or sore throat (you may have less white blood cells than normal). In certain cases, the infection may be severe and could lead to death.
• Shortness of breath or dry cough, difficulty or pain when swallowing, pain or burning in throat.
• Sudden breathlessness or intense pain in chest and legs, which may indicate a blood clot in the blood vessels of your lungs.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• abnormal blood test results including anaemia
• bleeding from the gums, nose or mouth, any bleeding that will not stop, reddish or pink urine, unexpected bruising (you may have less platelets in your blood than is normal).
• dehydration
• conjunctivitis (pink eye), abnormal or excessive secretion of tears, dry eyes
• numbness, taste disturbances, dizziness, weakness in the hands and lower arms; cramping; involuntary contractions or twitching
• nausea, vomiting, anorexia, constipation, mouth sores, sore throat, diarrhoea, heartburn, abdominal pain
• abnormal liver test results
• skin rash, burning or prickling sensation, hair loss, rash with pink-red centre surrounded by a pale ring border and an outer pink-red ring, dark spots on the skin
• abnormal kidney function test results
• extreme tiredness (fatigue), raised body temperature, excess fluid in body tissue causing swelling, pain

Less frequent side effects:

• pancytopenia- combined low counts of white cells, red cells and platelets
• mini stroke, stroke
• colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding)
• interstitial pneumonitis (scarring of the air sacs of the lung)
• Hepatitis (inflammation of the liver)
• excessive urine production, reduced urine output, excessive thirst

The following side effects have been reported but the frequency for them to occur is not known:

• Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PEMTORI IV.

Store all medicines out of reach of children.

Powder: Store at or below 25 º C.

Reconstituted solution: Store between 2 – 8 º C (in a refrigerator) and use within 24 hours.

PEMTORI IV powder for solution for infusion is for single use only. Dispose of any unused solution in accordance with local requirement.

Keep the vial in the carton until required for use.

Do not use after the expiry date stated on the carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).