Mycophenolate Mofetil (Page 10 of 11)
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
17.1 Embryofetal Toxicity
Pregnancy loss and malformations
- Inform females of reproductive potential and pregnant women that use of mycophenolate mofetil 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)].
- 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 therapy and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence. Mycophenolate mofetil 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 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 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. 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 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 not to crush mycophenolate mofetil tablets and not to open mycophenolate mofetil capsules.
- Advise patients to avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules. 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 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 [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 [see Warnings and Precautions (5.12)].
17.11 Potential to Impair Driving and Use of Machinery
Advise patients that mycophenolate mofetil 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 [see Warnings and Precautions (5.14)].
Dispense with Medication Guide available at: www.avetpharma.com/product.
Manufactured by:
Strides Pharma Science Ltd.
Bengaluru – 562106, India
Manufactured for:
Avet Pharmaceuticals Inc.
East Brunswick, NJ 08816
1.866.901.DRUG (3784)
Revised: 12/2022
Dispense with Medication Guide available at: www.avetpharma.com/product. MEDICATION GUIDE | |||
Mycophenolate Mofetil Capsules, USP and Mycophenolate Mofetil Tablets, USP (mye” koe fen’ oh late moe’ fe til) | |||
Read the Medication Guide that comes with mycophenolate mofetil tablets and capsules 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? Mycophenolate mofetil 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 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 | |||
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o By phone at 1-800-617-8191 or o By visiting the REMS website at: www.mycophenolateREMS.com | |||
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 have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have: | |||
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Increased risk of getting serious infections. Mycophenolate mofetil weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil and can lead to hospitalizations and death. These serious infections can include:
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o weakness on one side of the body o you do not care about things you usually care about (apathy) | o you are confused or have problems thinking o you cannot control your muscles | ||
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Call your doctor right away if you have any of the following signs and symptoms of infection: | |||
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See “What are the possible side effects of mycophenolate mofetil?” for information about other serious side effects | |||
What is mycophenolate mofetil? • Mycophenolate mofetil is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant. Rejection is when the body’s immune system perceives the new organ as a “foreign” threat and attacks it • Mycophenolate mofetil is used with other medicines containing cyclosporine and corticosteroids | |||
Who should not take mycophenolate mofetil? Do not take mycophenolate mofetil if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil capsules and tablets. See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil capsules and tablets | |||
What should I tell my doctor before taking mycophenolate mofetil? Tell your doctor about all of your medical conditions, including if you: • have any digestive problems, such as ulcers • have Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome, or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take mycophenolate mofetil if you have one of these disorders • plan to receive any vaccines. People taking mycophenolate mofetil should not receive live vaccines. Some vaccines may not work as well during treatment with mycophenolate mofetil • are pregnant or plan to become pregnant. See “What is the most important information I should know about mycophenolate mofetil?” • are breastfeeding or plan to breastfeed. It is not known if mycophenolate mofetil passes into breast milk. You and your doctor will decide if you will take mycophenolate mofetil or breastfeed 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 works, and mycophenolate mofetil may affect how some medicines work Especially tell your doctor if you take: • birth control pills (oral contraceptives). See “What is the most important information I should know about mycophenolate mofetil?” • sevelamer (Renagel® , RenvelaTM). These products should be taken at least 2 hours after taking mycophenolate mofetil • acyclovir (Zovirax®), valacyclovir (Valtrex®), ganciclovir (CYTOVENE® -IV, Vitrasert®), valganciclovir (VALCYTE®) • rifampin (Rifater® , Rifamate® , Rimactane® , Rifadin®). • antacids that contain magnesium and aluminum (mycophenolate mofetil and the antacid should not be taken at the same time) • proton pump inhibitors (PPIs) (Prevacid® , Protonix®) • sulfamethoxazole/trimethoprim (BACTRIMTM , BACTRIM DSTM) • norfloxacin (Noroxin®) and metronidazole (Flagyl® , Flagyl® ER, Flagyl® IV, Metro IV, Helidac® , PyleraTM) • ciprofloxacin (Cipro® , Cipro® XR, Ciloxan® , Proquin® XR) and amoxicillin plus clavulanic acid (Augmentin® , Augmentin XRTM). • azathioprine (Azasan® , Imuran®) • cholestyramine (Questran Light® , Questran® , Locholest Light, Locholest, Prevalite®) Know the medicines you take. Keep a list of them to show to your doctor or nurse and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor | |||
How should I take mycophenolate mofetil?
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What should I avoid while taking mycophenolate mofetil? • Avoid becoming pregnant. (See “ What is the most important information I should know about mycophenolate mofetil?”) • Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take mycophenolate mofetil have a higher risk of getting skin cancer (See “ What is the most important information I should know about mycophenolate mofetil?”). Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen with a high protection factor. This is especially important if your skin is very fair or if you have a family history of skin cancer • You should not donate blood while taking mycophenolate mofetil and for at least 6 weeks after stopping mycophenolate mofetil. • You should not donate sperm while taking mycophenolate mofetil and for 90 days after stopping mycophenolate mofetil. • Mycophenolate mofetil may influence your ability to drive and use machines (See “What are the possible side effects of mycophenolate mofetil?”. If you experience drowsiness, confusion, dizziness, tremor, or low blood pressure during treatment with mycophenolate mofetil, you should be cautious about driving or using heavy machines | |||
What are the possible side effects of mycophenolate mofetil? Mycophenolate mofetil may cause serious side effects, including:
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o white blood cells, especially neutrophils. Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 1 month to 6 months after your transplant. o red blood cells. Red blood cells carry oxygen to your body tissues. You have a higher chance of getting severe anemia when your red blood cell count is low. o platelets. Platelets help with blood clotting. | |||
Your doctor will do blood tests before you start taking mycophenolate mofetil and during treatment with mycophenolate mofetil to check your blood cell counts. Tell your doctor right away if you have any signs of infection (See “What is the most important information I should know about mycophenolate mofetil?”), including any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting. | |||
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The most common side effects of mycophenolate mofetil include: | |||
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Side effects that can happen more often in children than in adults taking mycophenolate mofetil include: | |||
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These are not all of the possible side effects of mycophenolate mofetil. 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. You may also report side effects to Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. | |||
How should I store mycophenolate mofetil capsules and tablets?
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