INDICATIONS AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

What is REDITREX?

REDITREX is a single dose prefilled syringe containing a prescription medicine, methotrexate. Methotrexate is used to:

 

• treat certain adults with severe, active rheumatoid arthritis (RA), and children with active polyarticular juvenile
idiopathic arthritis (pJIA), after treatment with other medicines including non-steroidal anti-inflammatory drugs
(NSAIDS) have been used and did not work well.

 

• control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have been used and did not work well.

 

REDITREX is available in doses of 7.5, 10, 12.5, 15, 17.5, 20, 22.5 and 25 mg. Your doctor will prescribe a different way to take methotrexate if you need to take methotrexate by mouth or in some other way. Your doctor may also change your prescription if your dose does not match the available REDITREX doses, such as doses less than 7.5 mg, or more than 25 mg, or doses between the available REDITREX doses.
REDITREX should not be used for the treatment of cancer.
REDITREX should not be used for the treatment of children with psoriasis.

What is the most important information I should know about REDITREX?

This product includes the following boxed warning.

REDITREX can cause serious side effects that can lead to death including:

1. Organ system toxicity. People who use methotrexate for the treatment of cancer, psoriasis, or rheumatoid arthritis, have an increased risk of death from organ toxicity. Types of organ toxicity can include:

 

• gastrointestinal
• bone marrow
• liver
• immune system
• nerve
• lung
• kidneys
• skin

 

Your doctor will do blood tests and other types of tests before you use and while you are using REDITREX to check for signs and symptoms of organ toxicity. Call your doctor right away if you have any of the following symptoms of organ toxicity.

 

• vomiting
• diarrhea
• mouth sores
• fever
• confusion
• weakness
• temporary blindness
• seizures
• headache
• back pain
• neck stiffness
• paralysis
• irritability
• sleepiness
• problems with coordination
• dry cough
• trouble breathing
• severe skin rash

 

2. Women who are pregnant are at increased risk for death of the baby and birth defects. Women who are pregnant or who plan to become pregnant must not use REDITREX. A pregnancy test should be performed before women start using REDITREX.

 

Contraception should be used by both females and males while using REDITREX.

 

Pregnancy should be avoided if either partner is using REDITREX:

 

• during and for a minimum of 3 months after treatment with REDITREX for males.
• during and for at least 1 menstrual cycle after treatment with REDITREX for females.

 

Do not use REDITREX if you:

 

• are pregnant or planning to become pregnant.
• are breastfeeding. Methotrexate can pass into your breastmilk and may harm your baby. Do not breastfeed while
using REDITREX. Talk to your doctor about the best way to feed your baby if you use REDITREX.
• have alcohol problems (alcoholism).
• have liver problems.
• have problems fighting infection (immunodeficiency syndrome).
• have been told you have (or think you have) a blood disorder such as low levels of white blood cells, red blood cells (anemia), or platelets.
• have had an allergy to methotrexate or any of the ingredients in REDITREX. See the end of this leaflet for a complete list of ingredients in REDITREX.

 

Talk to your doctor before taking this medicine if you have any of these conditions.

What are the possible side effects of REDITREX?

REDITREX may cause serious side effects, including:
fertility problems. Methotrexate, the active ingredient in REDITREX may affect your ability to have a baby. Males may have a decreased sperm count, and females may have changes to their menstrual cycle. This can happen while using REDITREX and for a short period of time after you stop.
certain cancers. Some people who have taken methotrexate have had a certain type of cancer called Non-Hodgkin’s lymphoma and other tumors. Your doctor may tell you to stop using REDITREX if this happens.
tissue and bone problems. Taking methotrexate while having radiation therapy may increase the risk of your tissue or bone not receiving enough blood. This may lead to death of the tissue or bone.

 

Common side effects of REDITREX include:

 

• nausea
• stomach pain
• indigestion (dyspepsia)
• mouth sores
• rash
• burning skin lesions
• stuffy or runny nose and sore throat
• diarrhea
• abnormal liver function tests
• vomiting
• headache
• lung problems
• bronchitis
• low red, white, and platelet blood cell count
• hair loss
• dizziness
• sensitivity to light

 

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

 

These are not all the possible side effects of REDITREX. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Before you use REDITREX, tell your doctor if you have any other medical conditions.

 

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

 

REDITREX may affect how other medicines work, and other medicines may affect how REDITREX works causing side effects. Ask your doctor or pharmacist for a list of medicines if you are not sure.

 

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

 

What should I avoid while using REDITREX?

 

• Do not drink alcohol while using REDITREX. Drinking alcohol can increase your chances of getting serious side effects.
• REDITREX can cause dizziness and tiredness. Do not drive a car, operate machinery, or do anything that needs you to be alert until you know how REDITREX affects you.
• Certain vaccinations should be avoided while using REDITREX. Talk to your doctor before you or members of your household receive any vaccines.