Mycophenolate Mofetil (Page 10 of 11)
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
17.1 Embryofetal Toxicity
Pregnancy loss and malformations
- Inform females of reproductive potential and pregnant women that use of mycophenolate mofetil for oral suspension during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Advise that they must use an acceptable form of contraception [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
- Encourage pregnant women to enroll in the Pregnancy Exposure Registry. This registry monitors pregnancy outcomes in women exposed to mycophenolate [see Use in Specific Populations (8.1)].
Contraception
- Discuss pregnancy testing, pregnancy prevention and planning with females of reproductive potential [see Use in Specific Populations (8.3)].
- Females of reproductive potential must use an acceptable form of birth control during the entire mycophenolate mofetil for oral suspension therapy and for 6 weeks after stopping mycophenolate mofetil for oral suspension, unless the patient chooses abstinence. Mycophenolate mofetil for oral suspension may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended [see Use in Specific Populations (8.3)].
- For patients who are considering pregnancy, discuss appropriate alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil for oral suspension should be discussed with the patient.
- Advise sexually active male patients and/or their partners to use effective contraception during the treatment of the male patient and for at least 90 days after cessation of treatment. This recommendation is based on findings of animal studies [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
17.2 Development of Lymphoma and Other Malignancies
- Inform patients that they are at increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.2)].
- Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use of broad-spectrum sunscreen with high protection factor.
17.3 Increased Risk of Serious Infections
Inform patients that they are at increased risk of developing a variety of infections due to immunosuppression. Instruct them to contact their physician if they develop any of the signs and symptoms of infection explained in the Medication Guide[see Warnings and Precautions (5.3)].
17.4 Blood Dyscrasias
Inform patients that they are at increased risk for developing blood adverse effects such as anemia or low white blood cells. Advise patients to immediately contact their healthcare provider if they experience any evidence of infection, unexpected bruising, or bleeding, or any other manifestation of bone marrow suppression [see Warnings and Precautions (5.4)].
17.5 Gastrointestinal Tract Complications
Inform patients that mycophenolate mofetil for oral suspension can cause gastrointestinal tract complications including bleeding, intestinal perforations, and gastric or duodenal ulcers. Advise the patient to contact their healthcare provider if they have symptoms of gastrointestinal bleeding, or sudden onset or persistent abdominal pain [see Warnings and Precautions (5.5)].
17.6 Acute Inflammatory Syndrome
Inform patients that acute inflammatory reactions have been reported in some patients who received mycophenolate mofetil for oral suspension. Some reactions were severe, requiring hospitalization. Advise patients to contact their physician if they develop fever, joint stiffness, joint pain or muscle pains [see Warnings and Precautions (5.7)].
17.7 Immunizations
Inform patients that mycophenolate mofetil for oral suspension can interfere with the usual response to immunizations. Before seeking vaccines on their own, advise patients to discuss first with their physician [see Warnings and Precautions (5.8)].
17.8 Administration Instructions
- Advise patients to avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil for oral suspension. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water.
- Advise patients to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case they should continue to take mycophenolate mofetil for oral suspension at the usual times.
17.9 Blood Donation
Advise patients not to donate blood during therapy and for at least 6 weeks following discontinuation of mycophenolate mofetil for oral suspension [see Warnings and Precautions (5.11)].
17.10 Semen Donation
Advise males of childbearing potential not to donate semen during therapy and for 90 days following discontinuation of mycophenolate mofetil for oral suspension [see Warnings and Precautions (5.12)].
17.11 Potential to Impair Driving and Use of Machinery
Advise patients that mycophenolate mofetil for oral suspension can affect the ability to drive or operate machines. Patients should avoid driving or operating machines if they experience somnolence, confusion, dizziness, tremor or hypotension during treatment with mycophenolate mofetil for oral suspension [see Warnings and Precautions (5.14)].
Brands listed are the trademarks of their respective owners.
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia
Manufactured For:
Teva Pharmaceuticals Parsippany, NJ 07054
Rev. A 8/2023
MEDICATION GUIDE
Mycophenolate Mofetil (mye” koe fen’ oh late moe’ fe til) for Oral Suspension | |
Read the Medication Guide that comes with mycophenolate mofetil for oral suspension before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. | |
What is the most important information I should know about mycophenolate mofetil for oral suspension? Mycophenolate mofetil for oral suspension can cause serious side effects, including: Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil for oral suspension during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects.
The purpose of this registry is to gather information about the health of you and your baby. Increased risk of getting certain cancers. People who take mycophenolate mofetil for oral suspension have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have: | |
|
|
Increased risk of getting serious infections. Mycophenolate mofetil for oral suspension weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil for oral suspension and can lead to hospitalizations and death. These serious infections can include:
| |
|
|
Call your doctor right away if you have any of the following signs and symptoms of infection: | |
|
|
See “What are the possible side effects of mycophenolate mofetil for oral suspension?” for information about other serious side effects. | |
What is mycophenolate mofetil for oral suspension?
| |
Who should not take mycophenolate mofetil for oral suspension? Do not take mycophenolate mofetil for oral suspension if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil for oral suspension. See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil for oral suspension. | |
What should I tell my doctor before taking mycophenolate mofetil for oral suspension? Tell your doctor about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines may affect the way mycophenolate mofetil for oral suspension works, and mycophenolate mofetil for oral suspension may affect how some medicines work. Especially tell your doctor if you take:
| |
How should I take mycophenolate mofetil for oral suspension?
| |
What should I avoid while taking mycophenolate mofetil for oral suspension?
| |
What are the possible side effects of mycophenolate mofetil for oral suspension? Mycophenolate mofetil for oral suspension may cause serious side effects, including:
| |
The most common side effects of mycophenolate mofetil for oral suspension include: | |
|
|
Side effects that can happen more often in children than in adults taking mycophenolate mofetil for oral suspension include: | |
|
|
These are not all of the possible side effects of mycophenolate mofetil for oral suspension. Tell your doctor about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
How should I store mycophenolate mofetil for oral suspension?
| |
General information about the safe and effective use of mycophenolate mofetil for oral suspension. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil for oral suspension for a condition for which it was not prescribed. Do not give mycophenolate mofetil for oral suspension to other people, even if they have the same symptoms that you have. It may harm them. | |
What are the ingredients in mycophenolate mofetil for oral suspension? Active ingredient: mycophenolate mofetil Inactive ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, corn syrup, maltodextrin, methylparaben, modified corn starch, natural flavor, sodium citrate anhydrous, sorbitol, soybean lecithin, and xanthan gum. Brands listed are the trademarks of their respective owners. Manufactured In Croatia By: Pliva Hrvatska d.o.o., Zagreb, Croatia Manufactured For: Teva Pharmaceuticals , Parsippany, NJ 07054 |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. A 8/2023
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/mycophenolate-mofetil-21/page/10/