Pemetrexed Hospira - Pemetrexed uses, dose and side effects

Pemetrexed Hospira is co-administered 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.

Pemetrexed Hospira is also used with cisplatin in the initial treatment of advanced lung cancer.

Pemetrexed Hospira can be prescribed to you if you have advanced lung cancer and your illness has responded to treatment or if it is largely unchanged after initial drug treatment.

In addition, Pemetrexed Hospira is used to treat advanced lung cancer whose disease has progressed, after other previous drug treatments have been used.

What you need to know before you use Pemetrexed Hospira

Do not use Pemetrexed Hospira

if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
if you are breastfeeding. You should stop breastfeeding during treatment with Pemetrexed Hospira.
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 taking Pemetrexed Hospira.

Talk to your doctor or pharmacist if you have or have had kidney problems, as you may not be able to get Pemetrexed Hospira.

Before each infusion, blood samples will be taken to find out if the function of the kidneys and liver is sufficient and to check that the amount of blood cells is sufficient to obtain Pemetrexed Hospira. 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 receiving 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 Pemetrexed Hospira may cause immediate or late side effects.

If you have recently been vaccinated, you should tell your doctor, as Pemetrexed Hospira in combination with vaccination may cause unwanted reactions.

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 Pemetrexed Hospira.

Children and young people

This medicine should not be used by children or adolescents as there is no experience with the medicine in children and adolescents under 18 years of age.

Other medicines and Pemetrexed Hospira

Tell your doctor if you are taking any medicine 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 pemetrexed and/or renal function status, your doctor will need to 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.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Treatment with pemetrexed should be avoided during pregnancy. Your doctor will discuss any risks involved in taking pemetrexed during pregnancy. Women should use effective contraception during treatment with pemetrexed.

Breast-feeding

Tell your doctor if you are breastfeeding. Breast-feeding should be discontinued during treatment with pemetrexed.

Fertility

Men are advised not to have children during and up to 6 months after pemetrexed treatment and should therefore use an effective method of contraception during pemetrexed treatment and up to 6 months after stopping treatment. If you plan to have children during treatment or the following 6 months after treatment, consult a doctor or pharmacist. You may want to seek advice on sperm preservation before starting treatment.

Driving and using machines

Treatment with Pemetrexed Hospira may make you feel tired. Be careful when driving or using machines.

Pemetrexed Hospira contains sodium

One 4 ml vial contains less than 1 mmol (23 mg) sodium, ie essentially ‘sodium-free’.

One 20 ml vial contains approximately 54 mg of sodium (the main ingredient in table salt/table salt). This corresponds to 2.7% of the maximum recommended daily sodium intake for adults.

A 40 ml vial contains approximately 108 mg of sodium (the main ingredient in table salt/table salt). This corresponds to 5.4% of the maximum recommended daily intake of sodium for adults.

How to use Pemetrexed Hospira

Pemetrexed Hospira is given at a dose of 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 correct 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 the Pemetrexed Hospira concentrate in sterile sodium chloride 9 mg/ml (0.9%) solution before giving it to you.

Pemetrexed Hospira is always given as an infusion to a friend. Infusion one lasts for about 10 minutes.

When Pemetrexed Hospira 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 approximately 30 minutes after the end of the Pemetrexed Hospira 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 Pemetrexed Hospira. The tablets are given to reduce the frequency and severity of the skin reactions that may occur during cancer treatment.

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 skate once a day during treatment with Pemetrexed Hospira. You will miss at least 5 doses during the seven days preceding the first dose of Pemetrexed Hospira. You should continue to take folic acid for 21 days after the last dose of Pemetrexed Hospira. You will also receive a vitamin B ₁₂ injection (1000 micrograms) the week before Pemetrexed Hospira infusion one and then approximately every 9 weeks (equivalent to 3 courses of Pemetrexed Hospira). Vitamin B ₁₂ and folic acid are given to reduce the potentially harmful effects of cancer treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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 or very common): if you have a temperature of 38º C or more, sweating, or other signs of an infection (because you may have a lower white blood cell count than normal, 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 serious 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, have a feeling of fainting, become short of breath, 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 bleeding that does not want to stop, reddish or pinkish urine, unexpected bruising (because you may have fewer platelets than normal, which is 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).

Side effects of Pemetrexed Hospira that may occur:

Very common (may affect more than 1 user in 10)

Infection
Sore throat
Low neutrophil count ( white blood cell type )
Low white blood cell count
Low hemoglobin ( anemia )
Pain, redness, swelling, or soreness in the mouth
Decreased appetite
Vomiting
Diarrhea
Nausea
Rash
Flaking skin
Abnormal blood counts showing reduced kidney function
Fatigue (fatigue)

Common (may affect up to 1 in 10 people)

Blood infection
Fever with low neutrophil count ( white blood cell type )
Reduced platelet count
Allergic reaction
Dehydration
Taste changes
Muscle weakness due to damage to motor nerves, especially in the arms and legs
Loss of sensation, burning pain, and unsteady gait due to damage to sensory nerves
Dizziness
Inflammation or swelling of the conjunctiva ( membrane at the outermost part of the eyelids and covering the whites of the eyes)
Dry eyes
Tear-filled eyes
Dried conjunctiva ( membrane on the outer part of the eyelids and covering the whites of the eyes) and cornea (the clear layer that protects the iris and pupil )
Swollen eyelids
Eye problems, such as dryness, tearing, irritation, and/or pain
Heart failure (a condition that affects the pumping power of your heart muscle)
Irregular heartbeat
Indigestion
Constipation
Abdominal pain
Liver: increase in the substances in the blood produced by the liver
Increased skin pigmentation
Itching
Rash on the body therewith red marks
Hair loss
Hives
Kidney failure
Decreased renal function
Fever
Pain
Excess fluid in body tissue, which causes swelling
Chest pain
Inflammation and ulceration of the mucous membranes that line the digestive tract

Uncommon (may affect up to 1 in 100 people)

Reduction in the number of red and white blood cells and platelets
Stroke
Type of stroke when an artery to the brain is blocked
Bleeding inside the skull
Angina (chest pain caused by decreased blood flow to the heart)
Myocardial infarction
Narrowing or blockage of the coronary arteries
Elevated heart rate
Reduced blood distribution to the limbs
Blood clots in the pulmonary blood vessels ( pulmonary embolism )
Inflammation and scarring of the lungs with respiratory problems
Passage of bright red blood from the anus
Bleeding in the gastrointestinal tract
Broken intestine
Inflammation of the esophageal mucosa (esophagus)
Colitis ( inflammation of the wall of the colon), which may be accompanied by bleeding from the intestines or rectum (seen only in combination with cisplatin)
Inflammation, edema, erythema, and erosion of the mucosal surface of the esophagus caused by radiation therapy
Inflammation of the lung caused by radiation therapy

Rare (may affect up to 1 in 1,000 people)

Destruction of red blood cells
Anaphylactic shock (severe allergic reaction )
Inflammatory conditions of the liver
Redness of the skin
Skin rash that may occur on skin that has previously been exposed to radiation therapy.

Very rare (may affect up to 1 in 10,000 people)

Infection of skin and soft tissue
Stevens-Johnson syndrome (a type of severe reaction to skin and mucous membranes that can be life-threatening)
Toxic epidermal necrolysis (a type of severe skin reaction that can be life-threatening)
An autoimmune condition that results in skin rashes and blisters on legs, arms, and abdomen
Inflammation of the skin characterized by the presence of bullous conditions with fluid-filled blistering)
Fragile skin, blisters, and erosion as well as scarring of the skin
Redness, pain, and swelling mainly in the lower legs
Inflammation of the skin and fat under the skin (pseudocellulitis)
Inflammation of the skin ( dermatitis )
Skin that becomes inflamed, itchy, red, cracked, and rough
Intense itchy spots

Has been reported (occurs in an unknown number of users)

A form of diabetes that is primarily based on kidney pathology
Kidney disorder involving tubular epithelial cells (which form renal tubules) death.

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.

If you have any side effects, talk to your doctor.

How to store Pemetrexed Hospira

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 vial label after EXP. The expiration date is the last day of the specified month.

This medicine has no special storage instructions.

Infusion solution: Chemical and physical in-use durability of pemetrexed infusion solution has been demonstrated for up to 24 hours at 2 ° C-8 ° C. From a microbiological perspective, the product should be used immediately after opening. If not used immediately, in-use storage times and conditions before use is the responsibility of the user. This storage should not be longer than 24 hours at 2 –C – 8 ºC.

Drugs administered parenterally should be visually inspected for particulate matter and discoloration before administration. If particles are observed, the solution should not be administered.

This medicine is for single use only. Any unused solution should be disposed of following local requirements.

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.

Contents of the pack and other information

Content declaration

The active substance is pemetrexed. One ml of concentrate contains pemetrexed disodium equivalent to 25 mg pemetrexed. Further dilution must be performed by healthcare professionals before administration.

One vial of 4 ml concentrate contains pemetrexed disodium equivalent to 100 mg pemetrexed.

One vial of 20 ml concentrate contains pemetrexed disodium equivalent to 500 mg pemetrexed.

One vial of 40 ml concentrate contains pemetrexed disodium equivalent to 1000 mg pemetrexed.

The other ingredients are monothioglycerol, sodium hydroxide (for pH adjustment), and water for injection. See also section 2 “Pemetrexed Hospira contains sodium”.

What the medicine looks like and the contents of the pack

Pemetrexed Hospira concentrate for solution for infusion (sterile concentrate) is a clear, colorless to the pale yellow or greenish-yellow solution that is practically free of visible particles in a glass vial.

Each pack contains a vial of 100 mg / 4 ml, 500 mg / 20 ml or 1000 mg / 40 ml pemetrexed (as pemetrexed disodium).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Service Company BVBA

High Road 10

1930 Zaventem