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 (2.4) 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 (2.5), 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 last 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 last 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 last dose [see Use in Specific Populations (8.2)].
PATIENT INFORMATION Pemetrexed (peh-meh-TREX-ed) Injection for intravenous use | ||||
---|---|---|---|---|
This Patient Information has been approved by the U.S. Food and Drug Administration. | Issued: 6/2022 | |||
What is Pemetrexed Injection? | ||||
Pemetrexed Injection is a prescription medicine used to treat: | ||||
| ||||
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:
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?
| ||||
What are the possible side effects of Pemetrexed Injection? | ||||
Pemetrexed Injection can cause serious side effects, including: | ||||
| ||||
The most common side effects of Pemetrexed Injection when given alone are: | ||||
|
|
| ||
The most common side effects of Pemetrexed Injection when given with cisplatin are: | ||||
|
| |||
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 tests 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. These are not all of the possible side effects of Pemetrexed Injection. 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 Pemetrexed Injection. 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 Pemetrexed Injection that is written for health professionals. | ||||
What are the ingredients in Pemetrexed Injection? Active ingredient: pemetrexed Inactive ingredient: monothioglycerol, water for injection and may contain sodium hydroxide for pH adjustment. Manufactured by: Zydus Hospira Oncology Private Ltd. Ahmedabad 382-213, Gujarat, India. Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA LAB-1432-1.0 For more information, please visit http://www.pfizer.com. |
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 (2.4) 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 (2.5), 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 last 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 last 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 last dose [see Use in Specific Populations (8.2)].
PATIENT INFORMATION Pemetrexed (peh-meh-TREX-ed) Injection for intravenous use | ||||
---|---|---|---|---|
This Patient Information has been approved by the U.S. Food and Drug Administration. | Issued: 6/2022 | |||
What is Pemetrexed Injection? | ||||
Pemetrexed Injection is a prescription medicine used to treat: | ||||
| ||||
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:
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?
| ||||
What are the possible side effects of Pemetrexed Injection? | ||||
Pemetrexed Injection can cause serious side effects, including: | ||||
| ||||
The most common side effects of Pemetrexed Injection when given alone are: | ||||
|
|
| ||
The most common side effects of Pemetrexed Injection when given with cisplatin are: | ||||
|
| |||
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 tests 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. These are not all of the possible side effects of Pemetrexed Injection. 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 Pemetrexed Injection. 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 Pemetrexed Injection that is written for health professionals. | ||||
What are the ingredients in Pemetrexed Injection? Active ingredient: pemetrexed Inactive ingredient: monothioglycerol, water for injection and may contain sodium hydroxide for pH adjustment. Manufactured by: Zydus Hospira Oncology Private Ltd. Ahmedabad 382-213, Gujarat, India. Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA LAB-1432-1.0 For more information, please visit http://www.pfizer.com. |
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 (2.4) 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 (2.5), 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 last 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 last 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 last dose [see Use in Specific Populations (8.2)].
PATIENT INFORMATION Pemetrexed (peh-meh-TREX-ed) Injection for intravenous use | ||||
---|---|---|---|---|
This Patient Information has been approved by the U.S. Food and Drug Administration. | Issued: 6/2022 | |||
What is Pemetrexed Injection? | ||||
Pemetrexed Injection is a prescription medicine used to treat: | ||||
| ||||
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:
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?
| ||||
What are the possible side effects of Pemetrexed Injection? | ||||
Pemetrexed Injection can cause serious side effects, including: | ||||
| ||||
The most common side effects of Pemetrexed Injection when given alone are: | ||||
|
|
| ||
The most common side effects of Pemetrexed Injection when given with cisplatin are: | ||||
|
| |||
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 tests 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. These are not all of the possible side effects of Pemetrexed Injection. 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 Pemetrexed Injection. 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 Pemetrexed Injection that is written for health professionals. | ||||
What are the ingredients in Pemetrexed Injection? Active ingredient: pemetrexed Inactive ingredient: monothioglycerol, water for injection and may contain sodium hydroxide for pH adjustment. Manufactured by: Zydus Hospira Oncology Private Ltd. Ahmedabad 382-213, Gujarat, India. Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA LAB-1432-1.0 For more information, please visit http://www.pfizer.com. |
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FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.