Patient information: uses, side effects, how to take - Axtle

What is AXTLE?

AXTLE is a prescription medicine used to treat:

a kind of lung cancer called non-squamous non-small cell lung cancer (NSCLC).

AXTLE is used:

○ as the first treatment in combination with pembrolizumab and platinum chemotherapy when your lung cancer with no abnormal EGFR or ALK gene has spread (advanced NSCLC).

○ as the first treatment in combination with cisplatin when your lung cancer has spread (advanced NSCLC).

○ alone as maintenance treatment after you have received 4 cycles of chemotherapy that contains platinum for first treatment of your advanced NSCLC and your cancer has not progressed.

alone when your lung cancer has returned or spread after prior chemotherapy.

AXTLE is not for use for the treatment of people with squamous cell non-small cell lung cancer.

a kind of cancer called malignant pleural mesothelioma. This cancer affects the lining of the lungs and chest wall. AXTLE is used in combination with cisplatin as the first treatment for malignant pleural mesothelioma that cannot be removed by surgery or you are not able to have surgery.

AXTLE has not been shown to be safe and effective in children.

Do not take AXTLE : if you have had a severe allergic reaction to any medicine that contains pemetrexed.

Before taking AXTLE, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems.
have had radiation therapy.
are pregnant or plan to become pregnant . AXTLE can harm your unborn baby.

Females who are able to become pregnant :

Your healthcare provider will check to see if you are pregnant before you start treatment with AXTLE.

You should use effective birth control (contraception) during treatment with AXTLE and for 6 months after the last dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with AXTLE.

Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with AXTLE and for 3 months after the last dose.

are breastfeeding or plan to breastfeed . It is not known if AXTLE passes into breast milk. Do not breastfeed during treatment with AXTLE and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you have kidney problems and take a medicine that contains ibuprofen . You should avoid taking ibuprofen for 2 days before, the day of, and 2 days after receiving treatment with AXTLE.

How is AXTLE given?

It is very important to take folic acid and vitamin B₁₂during your treatment with AXTLE to lower your risk of harmful side effects.

○ Take folic acid exactly as prescribed by your healthcare provider 1 time a day, beginning 7 days (1 week) before your first dose of AXTLE and continue taking folic acid until 21 days (3 weeks) after your last dose of AXTLE.

○ Your healthcare provider will give you vitamin B₁₂injections during treatment with AXTLE. You will get your first vitamin B₁₂injection 7 days (1 week) before your first dose of AXTLE, and then every 3 cycles.

Your healthcare provider will prescribe a medicine called corticosteroid for you to take 2 times a day for 3 days, beginning the day before each treatment with AXTLE.
AXTLE is given to you by intravenous (IV) infusion into your vein. The infusion is given over 10 minutes.
AXTLE is usually given once every 21 days (3 weeks).

What are the possible side effects of AXTLE?

AXTLE can cause serious side effects, including:

Low blood cell counts. Low blood cell counts can be severe, including low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), and low red blood cell counts (anemia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with AXTLE. Tell your healthcare provider right away if you have any signs of infection, fever, bleeding, or severe tiredness during your treatment with AXTLE.
Kidney problems, including kidney failure. AXTLE can cause severe kidney problems that can lead to death. Severe vomiting or diarrhea can lead to loss of fluids (dehydration) which may cause kidney problems to become worse. Tell your healthcare provider right away if you have a decrease in amount of urine.
Severe skin reactions. Severe skin reactions that may lead to death can happen with AXTLE. Tell your healthcare provider right away if you develop blisters, skin sores, skin peeling, or painful sores, or ulcers in your mouth, nose, throat or genital area.
Lung problems (pneumonitis). AXTLE can cause serious lung problems that can lead to death. Tell your healthcare provider right away if you get any new or worsening symptoms of shortness of breath, cough, or fever.
Radiation recall. Radiation recall is a skin reaction that can happen in people who have received radiation treatment in the past and are treated with AXTLE. Tell your healthcare provider if you get swelling, blistering, or a rash that looks like a sunburn in an area that was previously treated with radiation.

The most common side effects of AXTLE when given alone are:

tiredness ● nausea ● loss of appetite

The most common side effects of AXTLE when given with cisplatin are:

vomiting
swelling or sores in your mouth or sore throat
constipation
low white blood cell counts (neutropenia)
low platelet counts (thrombocytopenia)
low red blood cell counts (anemia)

The most common side effects of AXTLE when given with pembrolizumab and platinum chemotherapy are:

tiredness and weakness
constipation
loss of appetite
vomiting
shortness of breath
nausea
diarrhea
rash
cough
fever

AXTLE may cause fertility problems in males. This may affect your ability to father a child. It is not known if these effects are reversible. Talk to your healthcare provider if this is a concern for you.

Your healthcare provider will do blood tests to check for side effects during treatment with AXTLE. Your healthcare provider may change your dose of AXTLE, delay treatment, or stop treatment if you have certain side effects.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of AXTLE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at

1-800-FDA-1088.

General information about the safe and effective use of AXTLE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

You can ask your pharmacist or healthcare provider for information about AXTLE that is written for health professionals.

What are the ingredients in AXTLE?

Active ingredient: pemetrexed

Inactive ingredients: mannitol. Hydrochloric acid may have been added to adjust pH.

Manufactured for:

Avyxa Pharma, LLC

New Jersey 07054, USA

Made in India

For more information, call 1-888-520-0954.

Axtle (Pemetrexed): Uses, Side Effects and Dosage