What is Axtle?

Pemetrexed injection is used in combination with pembrolizumab and platinum cancer medicines to treat metastatic (cancer that has spread) non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK gene mutations. It is also used together with cisplatin to treat advanced or metastatic, non-squamous NSCLC.

Pemetrexed injection is also used as maintenance treatment of advanced or metastatic NSCLC that has not progressed after a previous 4-cycle treatment with platinum cancer medicines. It is also used to treat metastatic non-squamous NSCLC that has come back after a previous chemotherapy.

Pemetrexed injection is also used together with cisplatin to treat malignant pleural mesothelioma (cancer that affects the inside lining of the lungs and chest wall) that cannot be removed by surgery. Pemetrexed belongs to the group of medicines called antineoplastics.

This medicine is given only by or under the direct supervision of your doctor.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to stay in place for at least 10 minutes.

Your doctor will give you other medicines (eg, folic acid, vitamin B12, steroid medicine) before you receive this medicine and during treatment to help prevent unwanted effects. Follow your doctor's instructions on how and when to take these medicines.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies on the relationship of age to the effects of pemetrexed injection have not been performed in the pediatric population. Safety and effectiveness have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pemetrexed injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, anemia, thrombocytopenia, high blood pressure, neutropenia) or age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving pemetrexed injection.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Adenovirus Vaccine
• Amtolmetin Guacil
• Aspirin
• Bacillus of Calmette and Guerin Vaccine, Live
• Bromfenac
• Bufexamac
• Celecoxib
• Cholera Vaccine, Live
• Choline Salicylate
• Clonixin
• Dengue Tetravalent Vaccine, Live
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Influenza Virus Vaccine, Live
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Poliovirus Vaccine, Live
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sapropterin
• Smallpox Vaccine
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Typhoid Vaccine, Live
• Valdecoxib
• Yellow Fever Vaccine

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia (low red blood cells) or
• Bone marrow problems or
• Lung or breathing problems or
• Neutropenia (low while blood cells) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Pemetrexed and cisplatin can sometimes cause nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. You can get medicines to help control the nausea and vomiting. Talk with your doctor if you get any of these symptoms.

Pemetrexed can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, diarrhea, lower back or side pain, mouth sores, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Serious lung or breathing problems (eg, interstitial pneumonitis) may occur after you receive this medicine. Call your doctor right away if have any changes in your breathing after you receive this medicine.

Tell your doctor if you have received radiation treatment in the past. You may be more sensitive to the effects of this medicine (eg, pain and redness of the skin at the place of earlier radiation treatment).

If you have kidney problems, make sure your doctor knows if you are using an NSAID or pain or arthritis medicine, especially ibuprofen. Do not take ibuprofen at least 2 days before or 2 days after receiving this medicine. Taking ibuprofen during treatment with this medicine may increase your risks for bone marrow, kidney, and stomach or bowel problems.

If you plan to have children, talk with your doctor before using this medicine. Some men receiving this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.