MYCOPHENOLATE MOFETIL powder, for suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Tilgjengelig fra:

Ascend Laboratories, LLC

INN (International Name):

MYCOPHENOLATE MOFETIL

Sammensetning:

MYCOPHENOLATE MOFETIL 200 mg in 1 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants. Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. Mycophenolate mofetil intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN). Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191. Risk Summary Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see Human Data] . Oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients) [see Animal Data]. Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman. The estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively Data Human Data A spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in MMF exposed pregnancies, based on published data from pregnancy registries. Malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. Based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following MMF exposure. Animal Data In animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. Oral administration of MMF to pregnant rats from Gestational Day 7 to Day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to  0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA. Oral administration of MMF to pregnant rabbits from Gestational Day 7 to Day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA. Risk Summary There are no data on the presence of mycophenolate in human milk, or the effects on milk production. There are limited data in the National Transplantation Pregnancy Registry on the effects of mycophenolate on a breastfed child [see Data]. Studies in rats treated with MMF have shown mycophenolic acid (MPA) to be present in milk. Because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil or from the underlying maternal condition. Data Limited information is available from the National Transplantation Pregnancy Registry. Of seven infants reported by the National Transplantation Pregnancy Registry to have been breastfed while the mother was taking mycophenolate, all were born at 34-40 weeks gestation, and breastfed for up to 14 months. No adverse events were reported. Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. Pregnancy Planning For patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. Risks and benefits of mycophenolate mofetil should be discussed with the patient. Pregnancy Testing To prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL immediately before starting mycophenolate mofetil. Another pregnancy test with the same sensitivity should be done 8 to 10 days later. Repeat pregnancy tests should be performed during routine follow-up visits. Results of all pregnancy tests should be discussed with the patient. In the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. Contraception Female Patients Females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see Table 9 for acceptable contraception methods). Patients must use acceptable birth control during the entire mycophenolate mofetil therapy, and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence. Patients should be aware that mycophenolate mofetil reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness [see Drug Interactions (7.2)]. Table 9.    Acceptable Contraception Methods for Females of Reproductive Potential Pick from the following birth control options: - Intrauterine devices (IUDs) - Tubal sterilization - Patient’s partner vasectomy OR - Oral  Contraceptive Pill - Transdermal patch -   Vaginal ring - Injection - Implant   - Diaphragm with spermicide - Cervical cap with spermicide - Contraceptive sponge - Male condom - Female condom OR - Diaphragm with spermicide - Cervical cap with spermicide - Contraceptive sponge - Male condom - Female condom Male Patients Genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 1.25 times. Thus, the risk of genotoxic effects on sperm cells cannot be excluded. Based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. Also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolate mofetil and for at least 90 days after cessation of treatment [see Use in Special Populations (8.1), Nonclinical Toxicology (13.1), Patient Counseling Information (17.9)]. Safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants. Kidney Transplant Use of mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant (100 patients, 3 months to 18 years of age) [see Dosage and Administration (2.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.1)] Heart Transplant and Liver Transplant Use of mycophenolate mofetil in pediatric heart transplant and liver transplant patients is supported by adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. Additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [see Dosage and Administration (2.3, 2.4), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.1)]. Clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. In general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies. [see Adverse Reactions (6.1), Drug Interactions (7)].   Patients with Kidney Transplant No dosage adjustments are needed in kidney transplant patients experiencing delayed graft function postoperatively but patients should be carefully monitored [see Clinical Pharmacology (12.3)]. In kidney transplant patients with severe chronic impairment of the graft (GFR less than 25 mL/min/1.73 m2 ), no dose adjustments are necessary; however, doses greater than 1 g administered twice a day should be avoided. Patients with Heart and Liver Transplant No data are available for heart or liver transplant patients with severe chronic renal impairment. Mycophenolate mofetil may be used for heart or liver transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks. Patients with Kidney Transplant No dosage adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. However, it is not known whether dosage adjustments are needed for hepatic disease with other etiologies [see Clinical Pharmacology (12.3)]. Patients with Heart Transplant No data are available for heart transplant patients with severe hepatic parenchymal disease. Mycophenolate Mofetil For Oral Suspension Read this Instructions for Use before you take or give mycophenolate mofetil for the first time and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Important: - Always use the oral dispenser provided with mycophenolate mofetil for oral suspension to make sure you measure the right amount of medicine. If your mycophenolate mofetil for oral suspension does not come with the oral dispenser, contact your pharmacist. - Call your pharmacist if your oral dispenser is lost or damaged.  - Your pharmacist will write the expiration date on your mycophenolate mofetil for oral suspension bottle label. Do not use mycophenolate mofetil after the expiration date. -  Ask your doctor or pharmacist if you have any questions or are unsure about how to take or give the right amount of medicine. - The mycophenolate mofetil for oral suspension should not be mixed with any type of liquids before taking or giving the dose. - Do not let the mycophenolate mofetil for oral suspension come in contact with the skin. If this happens, wash the skin well with soap and water. If the mycophenolate mofetil for oral suspension gets in the eyes, rinse the eyes with plain water. - If you spill any mycophenolate mofetil for oral suspension, wipe it up using paper towels wet with water. Put the child-resistant bottle cap back on the bottle and wipe the outside of the bottle with wet paper towels. Supplies needed to take or give a dose of mycophenolate mofetil for oral suspension: To take or give a dose of mycophenolate mofetil for oral suspension, you will need the bottle of medicine and the oral dispenser provided with the medicine (See Figure 1 ). Your pharmacist will insert the bottle adapter in the mycophenolate mofetil for oral suspension bottle. Do not remove the bottle adapter from the bottle. Figure 1 Taking or giving a dose of mycophenolate mofetil for oral suspension: Step 1 : With the child-resistant cap on the bottle, shake the bottle well for about 5 seconds before each use. Step 2 : Open the bottle by firmly pressing down on the child-resistant bottle cap and turning it to the left (counterclockwise). Do not throw away the child-resistant bottle cap. Step 3: Place the bottle on a flat surface. Before inserting the tip of the oral dispenser into the bottle adapter, push the plunger completely down toward the tip of the oral dispenser. Use 1 hand to hold the bottle upright. Insert the oral dispenser tip firmly into the opening of the bottle adapter.  Step 4 : Carefully turn the bottle upside down with the oral dispenser tip in place. Slowly pull the plunger down to withdraw your prescribed dose. Do not pull the plunger out of the oral dispenser (See Figure 2 ).   Figure 2 Step 5 : Leave the oral dispenser tip in the bottle and turn the bottle to an upright position. Slowly remove the oral dispenser tip from the bottle. If there are air bubbles in the oral dispenser or if you have withdrawn the wrong dose, insert the oral dispenser tip back into the bottle adapter while the bottle is in an upright position. Push the plunger gently all the way up so the mycophenolate mofetil for oral suspension flows back into the bottle. Repeat Step 4 .  Step 6 : Place the tip of the oral dispenser in the mouth directed towards the cheek and slowly push the plunger down until the oral dispenser is empty.  Step 7 : Put the child-resistant bottle cap back on the bottle and turn the cap to the right (clockwise) to close the bottle. Keep the bottle tightly closed after each use.  Step 8 : Rinse the oral dispenser under running tap water after each use: - Remove the plunger from the oral dispenser. - Rinse the oral dispenser and plunger with water only and let them air dry on a paper towel. -  When the oral dispenser and plunger are dry, put the plunger back in the oral dispenser for the next use. Do not throw away the oral dispenser. Store the oral dispenser in a clean, dry place. - Do not boil the oral dispenser. Do not use solvent-containing wipes to clean the oral dispenser. Do not use cloths or wipes to dry the oral dispenser.   How should I store mycophenolate mofetil for  oral suspension?   - Store the mycophenolate mofetil for oral suspension at room temperature between 59°F to 86°F (15°C to 30°C), for up to 60 days. You can also store the mycophenolate mofetil for oral suspension in the refrigerator between 36°F to 46°F (2°C to 8°C).  -  Do no t freeze. Keep mycophenolate mofetil for oral suspension and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: October, 2023 PT 2156-12

Produkt oppsummering:

Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . Mycophenolate mofetil tablets should not be crushed and mycophenolate mofetil capsules should not be opened or crushed. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in mycophenolate mofetil capsules, mycophenolate mofetil for oral suspension (before or after constitution), or mycophenolate mofetil intravenous (during or after preparation) [see Dosage and Administration (2.6 )]. Follow applicable special handling and disposal procedures1 .    

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

MYCOPHENOLATE MOFETIL - MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION
Ascend Laboratories, LLC
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MEDICATION GUIDE
Mycophenolate Mofetil For Oral Suspension USP 200 mg/ml
(mye" koe fen' oh late moe' fe til) 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?
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.
•
If you are a female who can become pregnant, your doctor must talk
with you about acceptable
birth control methods (contraceptive counseling) to use while taking
mycophenolate mofetil. You
should have 1 pregnancy test immediately before starting mycophenolate
mofetil and another
pregnancy test 8 to 10 days later. Pregnancy tests should be repeated
during routine follow-up
visits with your doctor. Talk to your doctor about the results of all
of your pregnancy tests. You
must use acceptable birth control during your entire mycophenolate
mofetil treatment and for 6
weeks after stopping mycophenolate mofetil, unless at any time you
choose to avoid sexual
intercourse (abstinence) with a man completely. Mycophenolate mofetil
decreases blood levels of
the hormones in birth control pills that you take by mouth. Birth
control pills may not work as
well while you take mycophenolate mofetil, and you could become
pregnant. If you take birth
control pills while using mycophenolate mofetil you must also use
another form of birth control.
Talk to your doctor about other birth control methods

Preparatomtale

MYCOPHENOLATE MOFETIL - MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION
ASCEND LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION
MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1995
WARNING: EMBRYOFETAL TOXICITY,
MALIGNANCIES AND SERIOUS INFECTIONS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
USE DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISKS OF FIRST
TRIMESTER PREGNANCY
LOSS AND CONGENITAL MALFORMATIONS. AVOID IF SAFER TREATMENT OPTIONS
ARE AVAILABLE.
FEMALES OF REPRODUCTIVE POTENTIAL MUST BE COUNSELED REGARDING
PREGNANCY
PREVENTION AND PLANNING _[SEE WARNINGS AND PRECAUTIONS (5.1)]._
INCREASED RISK OF DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES,
PARTICULARLY OF
THE SKIN_ [SEE WARNINGS AND PRECAUTIONS (5.2)]._
INCREASED SUSCEPTIBILITY TO INFECTIONS, INCLUDING OPPORTUNISTIC
INFECTIONS AND SEVERE
INFECTIONS WITH FATAL OUTCOMES_ [SEE WARNINGS AND PRECAUTIONS (5.3)]._
RECENT MAJOR CHANGES
Indications and Usage, Pediatric Heart or Liver Transplants
(1)…………… 6/2022
Dosage and Administration, Dosage Recommendations for Heart Transplant
Patients (2.3)………6/2022
Dosage and Administration, Dosage Recommendations for Liver Transplant
Patients (2.4)…6/2022
Warnings and Precautions, Serious Infections (5.3)……..10/2021
Warnings and Precautions, Acute Inflammatory Syndrome Associated with
Mycophenolate Products
(5.7)..10/2021
INDICATIONS AND USAGE
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated
for the prophylaxis of organ
rejection in adult and pediatric recipients 3 months of age and older
of allogeneic kidney, heart or liver
transplants, in combination with other immunosuppressants. (1)
DOSAGE AND ADMINISTRATION
ADULTS
DOSAGE
Kidney Transplant
1g twice daily, orally or intravenously (IV) over no
less than 2h (2.2)
Heart