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Methotrexate Vial

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Methotrexate Vial Quick Finder

17 PATIENT COUNSELING INFORMATION

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

Embryo-Fetal Toxicity

  • Advise...

17 PATIENT COUNSELING INFORMATION

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

Embryo-Fetal Toxicity

  • Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see

    Hypersensitivity Reactions

    Advise patients of the potential risk of hypersensitivity and that Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity to methotrexate. Advise patients to seek immediate medical attention if signs or symptoms of a hypersensitivity reaction occur [see

    Myelosuppression and Serious Infections

    Advise patient to contact their healthcare provider immediately for new onset fever, symptoms of infection, easy bruising or persistent bleeding [see

    Renal Toxicity

    Advise patients that methotrexate can cause renal toxicity. Advise patients to immediately contact their healthcare provider for signs or symptoms of renal toxicity, such as marked increases or decreases in urinary output [see

    Hepatotoxicity

    Advise patients to report signs or symptoms of hepatic toxicity and avoidance of alcohol during methotrexate treatment [see

    Neurotoxicity

    Advise patient to contact their healthcare provider immediately if they develop new neurological symptoms [see

    Gastrointestinal Toxicity

    Advise patients to contact their healthcare provider if they develop diarrhea, vomiting, or stomatitis. Advise patients to immediately contact their healthcare provider for high fever, rigors, persistent or severe abdominal pain, severe constipation, hematemesis, or melena [see

    Pulmonary Toxicity

    Advise patients to contact their healthcare provider for symptoms of cough, fever, and dyspnea [see

    Dermatologic Toxicity

    Advise patients that Methotrexate Injection can cause serious skin rash and to immediately contact their healthcare provider for new or worsening skin rash. Advise patients to avoid excessive sun exposure and to use sun protection measures [see

    Secondary Malignancies

    Advise patients on the risk of second primary malignancies during treatment with Methotrexate Injection [see

    Lactation

    Advise women not to breastfeed during treatment with methotrexate and for 1 week after the final dose [see

    Infertility

    Advise females and males of reproductive potential that methotrexate may cause impairment of fertility [see

    Drug Interactions

    • Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7)].
    • Instruct patients being treated for neoplastic indication to not take products containing folic acid or folinic acid unless directed to do so by their healthcare provider [see Warnings and Precautions (5.12)].


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What is the most important information I should know about Methotrexate Injection?


  • Your healthcare provider should do a pregnancy test before you start taking Methotrexate Injection to see if you are pregnant.
  • If you are being treated...

What is the most important information I should know about Methotrexate Injection?


  • Your healthcare provider should do a pregnancy test before you start taking Methotrexate Injection to see if you are pregnant.
  • If you are being treated for a medical condition other than cancer, do not receive or take Methotrexate Injection if you are pregnant. See " What are the possible side effects of Methotrexate Injection?" for more information about side effects.
Did you find an answer to your question? Yes No

What is Methotrexate Injection?


  • in combination with other chemotherapy medicines to treat acute lymphoblastic leukemia (ALL) to help prevent (prophylaxis) and to treat leukemia that spreads to the covering of the brain and spinal cord (meninges).
  • to treat...

What is Methotrexate Injection?


  • in combination with other chemotherapy medicines to treat acute lymphoblastic leukemia (ALL) to help prevent (prophylaxis) and to treat leukemia that spreads to the covering of the brain and spinal cord (meninges).
  • to treat non-Hodgkin lymphoma
  • in combination with other chemotherapy medicines to treat osteosarcoma
in adults:
  • in combination with other chemotherapy medicines to treat breast cancer
  • alone to treat squamous cell carcinoma of the head and neck
  • in combination with other chemotherapy medicines to treat gestational trophoblastic neoplasia
Methotrexate Injection is a prescription medicine used:
  • in adults to treat rheumatoid arthritis (RA)
  • in children to treat polyarticular juvenile idiopathic arthritis (pJIA)
  • in adults to treat severe psoriasis
Do not receive Methotrexate Injection if you:
  • have had a severe allergic reaction to Methotrexate Injection. See " What is the most important information I should know about Methotrexate Injection?"
  • you are pregnant and are being treated, or will be treated with Methotrexate Injection for rheumatoid arthritis, pJIA, or severe psoriasis, or for any disease other than cancer. Methotrexate Injection can cause harm to an unborn baby including birth defects or death of an unborn baby. See " What is the most important information I should know about Methotrexate Injection?"
Before you receive Methotrexate Injection, tell your healthcare provider about all of your medical conditions, including if you:
  • have kidney problems or are receiving dialysis treatments
  • have liver problems
  • have a history of neurologic problems, including seizures
  • drink-alcohol containing beverages during treatment with Methotrexate Injection, or if there are any changes in the amount of alcoholic beverages you drink
  • have fluid in your stomach-area (ascites)
  • have lung problems or fluid in your lungs (pleural effusion)
  • plan to have any surgeries with general anesthesia, including dental surgery
  • have stomach ulcers (peptic ulcer disease)
  • have ulcerative colitis
  • have recently received or are scheduled to receive a vaccine. You should not receive live vaccines during treatment with Methotrexate Injection.
  • are breastfeeding or plan to breastfeed. Methotrexate may pass into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of Methotrexate Injection.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines can affect the amount of methotrexate in your blood and can increase your risk for serious side effects.
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How will I receive or take Methotrexate Injection?

  • Depending on your medical condition and the dose of Methotrexate Injection that is prescribed by your healthcare provider, Methotrexate Injection can be given to you:
...

How will I receive or take Methotrexate Injection?

  • Depending on your medical condition and the dose of Methotrexate Injection that is prescribed by your healthcare provider, Methotrexate Injection can be given to you:
  • through an intravenous (IV) line in your vein
  • by injection into a large muscle (intramuscular injection)
  • injected under your skin (subcutaneous injection)
  • for certain diseases the preservative-free formulation of Methotrexate Injection can also be injected through your spine directly into your spinal fluid.
If you are receiving Methotrexate Injection to treat your cancer:
  • Your healthcare provider will decide your dose, how you will receive Methotrexate Injection, and how often you need to receive it, depending on your medical condition that is being treated.
  • If you are receiving high-dose Methotrexate Injection to treat your cancer, you will receive the medicine leucovorin to help prevent severe side effects ("rescue") to your bone marrow and other normal cells in your body. You will also receive intravenous (IV) fluids and other medicines to help prevent and treat side effects.
  • If you are receiving a "moderate-dose" of Methotrexate Injection to treat your cancer, you may also receive leucovorin.
  • Do not take folic acid or folinic acid during treatment with Methotrexate Injection to treat your cancer, unless your healthcare provider tells you to. Taking folic acid or folinic acid with Methotrexate Injection may make your treatment less effective.
  • Your healthcare provider will do blood tests to check for side effects during treatment with Methotrexate Injection.
  • Your healthcare provider may stop your treatment, change when you receive your treatment, or change the dose of your treatment if you have certain side effects while receiving Methotrexate Injection.
If you are receiving Methotrexate Injection for treatment of severe psoriasis, rheumatoid arthritis, or polyarticular juvenile idiopathic arthritis:
  • You should receive your Methotrexate Injection dose 1 time each week, not every day. Serious side effects and death have happened in people who mistakenly have taken Methotrexate every day instead of 1 time each week.
  • Take folic acid or folinic acid every day during treatment with Methotrexate Injection, as instructed by your healthcare provider, to help reduce the chance of developing certain side effects, such as mouth sores.
  • If you receive too much Methotrexate Injection call your healthcare provider or go to your nearest hospital emergency room right way. You will need to receive a medicine as soon as possible to help reduce side effects that could be severe and could cause death.
In all patients receiving Methotrexate Injection:
  • If you miss receiving a dose of Methotrexate Injection, call your healthcare provider for instructions about when to receive your next dose of Methotrexate Injection.
Did you find an answer to your question? Yes No

What are the possible side effects of Methotrexate Injection?


  • See " What is the most important information I should know about Methotrexate Injection?"
  • Tumor lysis syndrome (TLS). TLS is caused by the...

What are the possible side effects of Methotrexate Injection?


  • See " What is the most important information I should know about Methotrexate Injection?"
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS if you are receiving Methotrexate Injection as a cancer treatment. Your healthcare provider will treat you as needed to prevent or manage TLS if you develop it during treatment with Methotrexate Injection.
  • New (secondary) cancers. New (secondary) cancers can happen in people who take or receive Methotrexate Injection at any dose.
    • Certain blood cancers can happen during treatment with low-dose Methotrexate Injection. In some cases, these blood cancers may completely go away (regress completely) after Methotrexate Injection is stopped.
    • If you develop one of these blood cancers during treatment with Methotrexate Injection, your healthcare provider will stop your treatment, and treat as needed if the new cancer does not go away after Methotrexate Injection is stopped.
  • Increased risk of soft tissue and bone problems due to receiving Methotrexate Injection in combination with radiation therapy. In people who receive Methotrexate Injection, some soft tissue in your body may die and some bone cells may die. People who receive radiation therapy in combination with Methotrexate Injection have an increased risk of this happening.
  • mouth sores or ulcers
  • nausea
  • decreased white blood cell count. See " What is the most important information I should know about Methotrexate Injection?"
  • upset stomach
Possible fertility problems (infertility) in males and females.
Did you find an answer to your question? Yes No

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


Medicines are sometimes prescribed for purposes other...

General information about the safe and effective use of Methotrexate 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 Methotrexate Injection that is written for health professionals.

Did you find an answer to your question? Yes No

What are the ingredients in Methotrexate Injection?


Inactive ingredients for Methotrexate Injection with Preservative:

Logo

...

What are the ingredients in Methotrexate Injection?


Inactive ingredients for Methotrexate Injection with Preservative:

Logo

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Full Patient Information

...

Full Patient Information

17 PATIENT COUNSELING INFORMATION

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

Embryo-Fetal Toxicity

  • Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see

    Hypersensitivity Reactions

    Advise patients of the potential risk of hypersensitivity and that Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity to methotrexate. Advise patients to seek immediate medical attention if signs or symptoms of a hypersensitivity reaction occur [see

    Myelosuppression and Serious Infections

    Advise patient to contact their healthcare provider immediately for new onset fever, symptoms of infection, easy bruising or persistent bleeding [see

    Renal Toxicity

    Advise patients that methotrexate can cause renal toxicity. Advise patients to immediately contact their healthcare provider for signs or symptoms of renal toxicity, such as marked increases or decreases in urinary output [see

    Hepatotoxicity

    Advise patients to report signs or symptoms of hepatic toxicity and avoidance of alcohol during methotrexate treatment [see

    Neurotoxicity

    Advise patient to contact their healthcare provider immediately if they develop new neurological symptoms [see

    Gastrointestinal Toxicity

    Advise patients to contact their healthcare provider if they develop diarrhea, vomiting, or stomatitis. Advise patients to immediately contact their healthcare provider for high fever, rigors, persistent or severe abdominal pain, severe constipation, hematemesis, or melena [see

    Pulmonary Toxicity

    Advise patients to contact their healthcare provider for symptoms of cough, fever, and dyspnea [see

    Dermatologic Toxicity

    Advise patients that Methotrexate Injection can cause serious skin rash and to immediately contact their healthcare provider for new or worsening skin rash. Advise patients to avoid excessive sun exposure and to use sun protection measures [see

    Secondary Malignancies

    Advise patients on the risk of second primary malignancies during treatment with Methotrexate Injection [see

    Lactation

    Advise women not to breastfeed during treatment with methotrexate and for 1 week after the final dose [see

    Infertility

    Advise females and males of reproductive potential that methotrexate may cause impairment of fertility [see

    Drug Interactions

    • Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see
      This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 3/2021
      Patient Information
      METHOTREXATE (Meth-oh-trex-ate)
      Injection
      for intravenous, intramuscular,
      subcutaneous, or intrathecal use
      What is the most important information I should know about Methotrexate Injection?
      Methotrexate Injection can cause serious side effects that may be severe and lead to death, including:
      Harm to an unborn baby, including birth defects or death of an unborn baby.
      Females who can become pregnant:
      • Your healthcare provider should do a pregnancy test before you start taking Methotrexate Injection to see if you are pregnant.
      • If you are being treated for a medical condition other than cancer, do not receive or take Methotrexate Injection if you are pregnant. See " What are the possible side effects of Methotrexate Injection?" for more information about side effects.
      What is Methotrexate Injection?
      Methotrexate Injection is a prescription medicine used:
      in adults and children:
      • in combination with other chemotherapy medicines to treat acute lymphoblastic leukemia (ALL) to help prevent (prophylaxis) and to treat leukemia that spreads to the covering of the brain and spinal cord (meninges).
      • to treat non-Hodgkin lymphoma
      • in combination with other chemotherapy medicines to treat osteosarcoma
      in adults:
      • in combination with other chemotherapy medicines to treat breast cancer
      • alone to treat squamous cell carcinoma of the head and neck
      • in combination with other chemotherapy medicines to treat gestational trophoblastic neoplasia
      Methotrexate Injection is a prescription medicine used:
      • in adults to treat rheumatoid arthritis (RA)
      • in children to treat polyarticular juvenile idiopathic arthritis (pJIA)
      • in adults to treat severe psoriasis
      Do not receive Methotrexate Injection if you:
      • have had a severe allergic reaction to Methotrexate Injection. See " What is the most important information I should know about Methotrexate Injection?"
      • you are pregnant and are being treated, or will be treated with Methotrexate Injection for rheumatoid arthritis, pJIA, or severe psoriasis, or for any disease other than cancer. Methotrexate Injection can cause harm to an unborn baby including birth defects or death of an unborn baby. See " What is the most important information I should know about Methotrexate Injection?"
      Before you receive Methotrexate Injection, tell your healthcare provider about all of your medical conditions, including if you:
      • have kidney problems or are receiving dialysis treatments
      • have liver problems
      • have a history of neurologic problems, including seizures
      • drink-alcohol containing beverages during treatment with Methotrexate Injection, or if there are any changes in the amount of alcoholic beverages you drink
      • have fluid in your stomach-area (ascites)
      • have lung problems or fluid in your lungs (pleural effusion)
      • plan to have any surgeries with general anesthesia, including dental surgery
      • have stomach ulcers (peptic ulcer disease)
      • have ulcerative colitis
      • have recently received or are scheduled to receive a vaccine. You should not receive live vaccines during treatment with Methotrexate Injection.
      • are breastfeeding or plan to breastfeed. Methotrexate may pass into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of Methotrexate Injection.
      Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines can affect the amount of methotrexate in your blood and can increase your risk for serious side effects.
      How will I receive or take Methotrexate Injection?
      • Depending on your medical condition and the dose of Methotrexate Injection that is prescribed by your healthcare provider, Methotrexate Injection can be given to you:
      • through an intravenous (IV) line in your vein
      • by injection into a large muscle (intramuscular injection)
      • injected under your skin (subcutaneous injection)
      • for certain diseases the preservative-free formulation of Methotrexate Injection can also be injected through your spine directly into your spinal fluid.
      If you are receiving Methotrexate Injection to treat your cancer:
      • Your healthcare provider will decide your dose, how you will receive Methotrexate Injection, and how often you need to receive it, depending on your medical condition that is being treated.
      • If you are receiving high-dose Methotrexate Injection to treat your cancer, you will receive the medicine leucovorin to help prevent severe side effects ("rescue") to your bone marrow and other normal cells in your body. You will also receive intravenous (IV) fluids and other medicines to help prevent and treat side effects.
      • If you are receiving a "moderate-dose" of Methotrexate Injection to treat your cancer, you may also receive leucovorin.
      • Do not take folic acid or folinic acid during treatment with Methotrexate Injection to treat your cancer, unless your healthcare provider tells you to. Taking folic acid or folinic acid with Methotrexate Injection may make your treatment less effective.
      • Your healthcare provider will do blood tests to check for side effects during treatment with Methotrexate Injection.
      • Your healthcare provider may stop your treatment, change when you receive your treatment, or change the dose of your treatment if you have certain side effects while receiving Methotrexate Injection.
      If you are receiving Methotrexate Injection for treatment of severe psoriasis, rheumatoid arthritis, or polyarticular juvenile idiopathic arthritis:
      • You should receive your Methotrexate Injection dose 1 time each week, not every day. Serious side effects and death have happened in people who mistakenly have taken Methotrexate every day instead of 1 time each week.
      • Take folic acid or folinic acid every day during treatment with Methotrexate Injection, as instructed by your healthcare provider, to help reduce the chance of developing certain side effects, such as mouth sores.
      • If you receive too much Methotrexate Injection call your healthcare provider or go to your nearest hospital emergency room right way. You will need to receive a medicine as soon as possible to help reduce side effects that could be severe and could cause death.
      In all patients receiving Methotrexate Injection:
      • If you miss receiving a dose of Methotrexate Injection, call your healthcare provider for instructions about when to receive your next dose of Methotrexate Injection.
      What are the possible side effects of Methotrexate Injection?
      Methotrexate Injection can cause serious side effects, including:
      • See " What is the most important information I should know about Methotrexate Injection?"
      • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS if you are receiving Methotrexate Injection as a cancer treatment. Your healthcare provider will treat you as needed to prevent or manage TLS if you develop it during treatment with Methotrexate Injection.
      • New (secondary) cancers. New (secondary) cancers can happen in people who take or receive Methotrexate Injection at any dose.
        • Certain blood cancers can happen during treatment with low-dose Methotrexate Injection. In some cases, these blood cancers may completely go away (regress completely) after Methotrexate Injection is stopped.
        • If you develop one of these blood cancers during treatment with Methotrexate Injection, your healthcare provider will stop your treatment, and treat as needed if the new cancer does not go away after Methotrexate Injection is stopped.
      • Increased risk of soft tissue and bone problems due to receiving Methotrexate Injection in combination with radiation therapy. In people who receive Methotrexate Injection, some soft tissue in your body may die and some bone cells may die. People who receive radiation therapy in combination with Methotrexate Injection have an increased risk of this happening.
      The most common side effects of Methotrexate Injection include:
      • mouth sores or ulcers
      • nausea
      • decreased white blood cell count. See " What is the most important information I should know about Methotrexate Injection?"
      • upset stomach
      Possible fertility problems (infertility) in males and females. Methotrexate Injection can cause fertility problems in males and females, and cause sperm production to stop in males, and menstrual problems in females. In females, your periods (menstrual cycle) may be irregular or completely stop when you receive Methotrexate Injection. Your periods may or may not return to normal following treatment. It is not known if your fertility will return after treatment. Talk to your healthcare provider about your risk for infertility if this is a concern for you.
      These are not all of the possible side effects of Methotrexate Injection.
      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 Methotrexate 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 Methotrexate Injection that is written for health professionals.
      What are the ingredients in Methotrexate Injection?
      Active ingredient: methotrexate.
      Inactive ingredients for Methotrexate Injection Preservative-free:
      sodium chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH to 8.5.
      Inactive ingredients for Methotrexate Injection with Preservative: benzyl alcohol and sodium chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH to 8.5.
      Distributed by: Hospira, Inc. Lake Forest, IL 60045
      LAB-1468-1.0

      Logo

      For more information, go to www.pfizer.com or call 1-800-438-1985.

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