Get the free THALOMID (thalidomide) Capsules Revised Package Insert - accessdata fda
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This document serves as a package insert for THALOMID, detailing important safety information, warnings, uses, and requirements for patients regarding the medication, particularly concerning birth
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How to fill out thalomid thalidomide capsules revised
How to fill out THALOMID (thalidomide) Capsules Revised Package Insert
01
Read the THALOMID Package Insert carefully before starting the medication.
02
Ensure you understand the indications for THALOMID treatment.
03
Check for any contraindications listed in the insert.
04
Follow the prescribed dosage schedule as specified in the insert.
05
Take THALOMID capsules exactly as instructed by your healthcare provider.
06
Monitor for any side effects or adverse reactions, as noted in the insert.
07
Keep the medication out of reach of children and do not share with others.
Who needs THALOMID (thalidomide) Capsules Revised Package Insert?
01
Individuals with multiple myeloma.
02
Patients with certain complications from leprosy.
03
People who are part of a clinical trial involving THALOMID.
04
Patients who meet specific eligibility criteria as determined by their healthcare provider.
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People Also Ask about
Can thalomid have refills?
You will need a new prescription for each refill. This medicine causes severe birth defects or death to an unborn child. This can happen after just ONE capsule. Both men and women must agree to take steps to prevent exposure of this medicine to an unborn child.
How much does thalomid cost?
The cost for Thalomid 50 mg oral capsule is around $1,972 for a supply of 10 capsules, depending on the pharmacy you visit.
What is the drug thalidomide used for now?
And after more positive results, thalidomide was used as a treatment for leprosy in many countries. More recently, it has been used successfully to control some AIDS-related conditions, and as a targeted cancer drug for treating the symptoms of cancers such as multiple myeloma.
When should I stop taking thalidomide?
Your doctor will tell you when and where to have these tests. Stop taking thalidomide and call your doctor right away if you think you are pregnant, you have a late, irregular, or missed menstrual period, you have any change in your menstrual bleeding, or you have sex without using two forms of birth control.
What is the drug thalomid used for?
Thalidomide is used in combination with dexamethasone to treat multiple myeloma. This medicine is also used to treat moderate to severe new lesions of leprosy and as maintenance treatment to prevent and keep erythema nodosum leprosum (skin lesions of leprosy) from coming back.
What is the drug thalomid used for?
Thalidomide is used in combination with dexamethasone to treat multiple myeloma. This medicine is also used to treat moderate to severe new lesions of leprosy and as maintenance treatment to prevent and keep erythema nodosum leprosum (skin lesions of leprosy) from coming back.
Who can prescribe thalidomide?
Prescribing and taking thalidomide Only physicians and pharmacists registered with this program can prescribe and dispense thalidomide.
Who should not take thalomid?
THALOMID must not be used by pregnant females or by females who are able to get pregnant who are not using acceptable birth control or avoiding sex with a male.
Is thalidomide still available?
Thalidomide is an antineoplastic (cancer medicine) and leprostatic agent. This medicine is available only under a restricted distribution program called the Thalomid® REMS (Risk Evaluation and Mitigation Strategy) program.
Which program does the dispensing of thalomid require adherence to?
Only certified prescribers can prescribe THALOMID and only certified pharmacies can dispense THALOMID. In order to receive THALOMID, patients must be enrolled in the THALOMID REMS™ program and agree to follow the requirements.
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What is THALOMID (thalidomide) Capsules Revised Package Insert?
THALOMID (thalidomide) Capsules Revised Package Insert is a document that provides essential information about the drug THALOMID, including its uses, dosage, administration instructions, potential side effects, and safety information.
Who is required to file THALOMID (thalidomide) Capsules Revised Package Insert?
Pharmaceutical manufacturers and sponsors of THALOMID are required to file the Revised Package Insert with the appropriate regulatory authorities to ensure compliance with safety and efficacy standards.
How to fill out THALOMID (thalidomide) Capsules Revised Package Insert?
To fill out the THALOMID Capsules Revised Package Insert, complete each section with accurate and comprehensive data regarding the drug's indications, usage guidelines, side effects, contraindications, and other pertinent information, ensuring adherence to regulatory guidelines.
What is the purpose of THALOMID (thalidomide) Capsules Revised Package Insert?
The purpose of the THALOMID (thalidomide) Capsules Revised Package Insert is to inform healthcare professionals and patients about the medication's proper use, potential risks, and necessary precautions to promote safe and effective treatment.
What information must be reported on THALOMID (thalidomide) Capsules Revised Package Insert?
The information that must be reported on the THALOMID Capsules Revised Package Insert includes the drug's indications, dosages, contraindications, warnings, precautions, adverse reactions, drug interactions, patient counseling information, and storage conditions.
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