Pemetrexed (Page 5 of 6)

15 REFERENCES

1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Pemetrexed Injection is supplied as a clear, colorless to slightly yellowish or slightly yellow-greenish solution available in sterile single-dose vials at a 25 mg/mL concentration in the following package strengths.

Pemetrexed Injection 100 mg/4 mL (25 mg/mL) NDC 0480-4516-01

Pemetrexed Injection 500 mg/20 mL (25 mg/mL) NDC 0480-4514-01

Pemetrexed Injection 1 g/40 mL (25 mg/mL) NDC 0480-4515-01

Storage and Handling

Store under refrigeration between 2° to 8°C (36° to 46°F). Protect from light. Retain in carton until time of use.

Pemetrexed Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Do not Freeze.

Sterile, Nonpyrogenic, Preservative-free.

The vial stopper is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Premedication and Concomitant Medication: Instruct patients to take folic acid as directed and to keep appointments for vitamin B12 injections to reduce the risk of treatment-related toxicity. Instruct patients of the requirement to take corticosteroids to reduce the risks of treatment-related toxicity [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].

Myelosuppression: Inform patients of the risk of low blood cell counts and instruct them to immediately contact their physician for signs of infection, fever, bleeding, or symptoms of anemia [see Warnings and Precautions (5.1)].

Renal Failure: Inform patients of the risks of renal failure, which may be exacerbated in patients with dehydration arising from severe vomiting or diarrhea. Instruct patients to immediately contact their healthcare provider for a decrease in urine output [see Warnings and Precautions (5.2)].

Bullous and Exfoliative Skin Disorders: Inform patients of the risks of severe and exfoliative skin disorders. Instruct patients to immediately contact their healthcare provider for development of bullous lesions or exfoliation in the skin or mucous membranes [see Warnings and Precautions (5.3)].

Interstitial Pneumonitis: Inform patients of the risks of pneumonitis. Instruct patients to immediately contact their healthcare provider for development of dyspnea or persistent cough [see Warnings and Precautions (5.4)].

Radiation Recall: Inform patients who have received prior radiation of the risks of radiation recall. Instruct patients to immediately contact their healthcare provider for development of inflammation or blisters in an area that was previously irradiated [see Warnings and Precautions (5.5)].

Increased Risk of Toxicity with Ibuprofen in Patients with Renal Impairment: Advise patients with mild to moderate renal impairment of the risks associated with concomitant ibuprofen use and instruct them to avoid use of all ibuprofen containing products for 2 days before, the day of, and 2 days following administration of Pemetrexed Injection [see Dosage and Administration (2.4), Warnings and Precautions (5.6), and Drug Interactions (7)].

Embryo-Fetal Toxicity: Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with Pemetrexed Injection and for 6 months after the final dose. Advise females to inform their prescriber of a known or suspected pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with Pemetrexed Injection and for 3 months after the final dose [see Warnings and Precautions (5.7) and Use in Specific Populations (8.3)].

Lactation: Advise women not to breastfeed during treatment with Pemetrexed Injection and for 1 week after the final dose [see Use in Specific Populations (8.2)].

Manufactured In Romania By:
Sindan Pharma SRL
Bucharest 1, Romania 011171

Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054

Iss. 10/2021

PATIENT INFORMATION

Pemetrexed (pem” e trex’ ed) Injection, for intravenous use

What is Pemetrexed Injection?

Pemetrexed Injection is a prescription medicine used to treat:

  • a kind of lung cancer called non-squamous non-small cell lung cancer (NSCLC). Pemetrexed Injection is used:
    • 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.
It is not known if Pemetrexed Injection is safe and effective in children.
Do not take Pemetrexed Injection: if you have had a severe allergic reaction to any medicine that contains pemetrexed.

Before taking Pemetrexed Injection, 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. Pemetrexed Injection can harm your unborn baby.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with Pemetrexed Injection and for 6 months after the final dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Pemetrexed Injection.
    • Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with Pemetrexed Injection and for 3 months after the final dose.
  • are breastfeeding or plan to breastfeed. It is not known if pemetrexed passes into breast milk. Do not breastfeed during treatment with Pemetrexed Injection and for 1 week after the final 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 Pemetrexed Injection.

How is Pemetrexed Injection given?

  • It is very important to take folic acid and vitamin B12 during your treatment with Pemetrexed Injection 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 Pemetrexed Injection and continue taking folic acid until 21 days (3 weeks) after your last dose of Pemetrexed Injection.
    • Your healthcare provider will give you vitamin B12 injections during treatment with Pemetrexed Injection. You will get your first vitamin B12 injection 7 days (1 week) before your first dose of Pemetrexed Injection, 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 Pemetrexed Injection.
  • Pemetrexed Injection is given to you by intravenous (IV) infusion into your vein. The infusion is given over 10 minutes.
  • Pemetrexed Injection is usually given on Day 1 of each 21-day (3 weeks) cycle.

What are the possible side effects of Pemetrexed Injection?

Pemetrexed Injection 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 test to check your blood cell counts regularly during your treatment with Pemetrexed Injection. Tell your healthcare provider right away if you have any signs of infection, fever, bleeding, or severe tiredness during your treatment with Pemetrexed Injection.
  • Kidney problems, including kidney failure. Pemetrexed Injection 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 Pemetrexed Injection. 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). Pemetrexed Injection 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 Pemetrexed Injection. 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 Pemetrexed Injection when given alone are:

  • tiredness ● nausea ● loss of appetite

Pemetrexed Injection 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 test to check for side effects during treatment with Pemetrexed Injection. Your healthcare provider may change your dose of Pemetrexed Injection, 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.

General information about the safe and effective use of Pemetrexed Injection.

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

What are the ingredients in Pemetrexed Injection? Active ingredient: pemetrexedInactive ingredients: tromethamine, citric acid anhydrous, methionine and water for injection.

Manufactured In Romania By: Sindan Pharma SRL , Bucharest 1, Romania 011171Manufactured For: Teva Pharmaceuticals , Parsippany, NJ 07054For more information, call Teva at 1-888-838-2872.

This Patient Information has been approved by the U.S. Food and Drug Administration. Iss. 10/2021

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