Sellsept

CellCept is a drug that is the mainstay after organ transplantation.

Indications Sellseptah.

The drug can be used in combination with hormonal drugs (corticosteroids) and immunosuppressants (cyclosporine) for adults and children over twelve years of age. Indications are - prevention and therapeutic treatment of rejection of organs such as the heart, kidney and liver, as well as increasing the chances of survival of patients.

Release form

The medicine is available in the form of tablets or capsules with engraving. Ten pieces in a blister. The package may contain from five to ten plates.

Pharmacodynamics

To prevent and treat rejection of transplanted organs, the drug is used in combination with cyclosporine, hormones and antithymocyte globulin.

This helps to reduce the ineffectiveness of treatment in the first six months after transplantation, and in a daily dose of two grams it reduces the number of dead transplants and patient mortality in the year after transplantation, while in a daily dose of three grams, on the contrary, it increases the number of patients who drop out of the study early.

Compared to Azathioprine, CellCept has a significantly lower rate of death, rejection, and subsequent transplantation, while providing similar survival in patients receiving primary kidney transplants.

In preclinical studies, no carcinogenic effects or reduction in fertility in rats were detected when the recommended doses were doubled. MMF can cause chromosomal instability only at a dose that has a cytotoxic effect.

Animal tests indicate that if the dose is increased by almost 0.5 times during transplantation and by 0.3 times during heart transplantation, various developmental defects are caused in the first generation (without toxic effects on the mother).

The results of toxicological studies show that the organs of the hematopoietic and lymphatic systems are mainly affected.

Non-clinical toxicity data are consistent with adverse drug reactions.

Pharmacokinetics

After oral administration of the drug, immediate absorption and metabolism occur, forming the metabolite MFC. Bioavailability, when taken orally compared to intravenous administration of CellCept, is approximately 94%, but the concentration is not detected with this method of administration.

The concentration (by forty percent) and AUC (by thirty percent) indicators six months after the operation are higher than in the period up to forty days after it.

Eating food does not affect the absorption of MFC, but its concentration decreases by forty percent.

Six to twelve hours after taking the medication, there is a second increase in the concentration of CellCept. This indicates the onset of its hepatic-intestinal breakdown. If Cholestyramine is prescribed at the same time, the AUC will decrease by forty percent. This means the cessation of the hepatic-intestinal circulation. Research data show that MFC binds to plasma protein.

During the process of hepatic-intestinal breakdown, the drug is metabolized under the influence of glucuronyl transferase with the formation of phenolic glucuronide.

Excretion occurs mainly by the kidneys (about 93%), of which 87% is as MFCG and 0.99% as MPA. The remaining 6% is excreted in the feces. A large concentration of MFCG can be slightly excreted by hemodialysis, but this procedure usually does not remove MPA and MFCG. Bile acid secretagogues interrupt the hepatic-intestinal breakdown.

As studies show, two tablets of 500 mg are equivalent to four capsules of 250 mg.

The glomerular filtration rate is 30–75% higher in patients with severe chronic renal failure than in healthy individuals. There are no data on the frequent use of CellCept in this category of patients.

In people with alcoholic liver cirrhosis, the pharmacokinetics are not changed. This allows us to state that pathological processes in the liver parenchyma will not be a contraindication for the use of Selsset.

Dosing and administration

Therapeutic doses for using CellCept:

Warning:

• kidney transplant

The daily dose should not exceed 3 grams. However, studies show that taking two grams will be more effective.

• heart, liver transplant

The daily dose is no more than 3 g.

Kidney transplant unit therapy

Three grams per day should be taken. The initial dose should be taken as soon as possible after the transplant.

People with chronic renal failure: Do not consume more than two grams per day.

People over 65. Those who have had a kidney transplant should not take more than two grams.

Children from twelve years old:

• prevention of rejection of a transplanted kidney. For a surface area of up to one and a half meters - a dose of 750 mg 2 times a day, more than one and a half meters - two grams.
• kidney transplant rejection therapy. As with heart or liver transplants, there is no information on its possible use.

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Use Sellseptah. during pregnancy

CellCept significantly increases the likelihood of intrauterine fetal malformations (for example, abnormal development of organs and systems). Therefore, a patient planning a pregnancy should be warned about such possible consequences of taking the medication.

Treatment with the drug should not be started until there is a clear negative result of pregnancy. Before the start of therapy and six weeks after it, the patient should use two types of contraception during sexual intercourse or abstain from them during the treatment, even if she has been diagnosed with infertility.

CellCept therapy during gestation should only be used if the benefit to the mother outweighs the harm to the baby.

It is also necessary to make a choice between breastfeeding and CellCept therapy, since there is no information on the excretion of the drug in women's milk. However, it should be taken into account that, during the studies in rats, MMF was present in their milk.

Contraindications

The drug should not be used during periods of exacerbation of gastrointestinal tract pathologies and any personal sensitivity to its components.

Side effects Sellseptah.

Due to the presence of the underlying pathological process and the combined use of CellCept with other drugs, all undesirable effects from treatment.

Most often, patients may experience: diarrhea, decreased white blood cell levels, blood poisoning, and vomiting.

Lymphoma was registered in one percent of patients who had undergone organ transplantation, took CellCepts together with other immunosuppressants and were under medical observation for at least one year. Skin carcinoma (except melanoma) was detected in 1.6-4.2% of cases, other types - up to two percent. Observations of patients for another two years did not make any significant changes in the data on malignant neoplasms that arose after organ transplantation.

With an increase in the degree of immunosuppression, the risk of developing infections that occur in people with severely weakened immunity increases proportionally. The most common in this case were: candidiasis of the skin and mucous membranes, as well as herpes.

In children, patients taking CellCept experience side effects such as diarrhea and anemia more often than adults (especially under six years of age), but the type and frequency of all negative effects are similar to adults.

In old age, the risk of various adverse reactions of the body to the use of CellCept is somewhat higher than in younger patients. Therefore, this category of patients should be prescribed a weaker dose (two grams per day).

Of the unregistered side effects, the most common are:

1. Colitis
2. Inflammation of the pancreas
3. Meningitis
4. Leukoencephalopathy, multifocal type
5. Fetal developmental abnormalities

Overdose

Information on drug overdose has not been registered. However, that which was obtained during studies allows us to talk about the probable occurrence of immunosuppression.

If agranulocytosis occurs in a patient, the dose should be reduced immediately or CellCept should be discontinued. Cholestyramine can also be used for removal, and hemodialysis will be virtually ineffective.

Interactions with other drugs

1. Acyclovir. In renal failure, the combined use of drugs will lead to an increase in their concentration in the serum.
2. Ganciclovir. Does not affect pharmacokinetics. But when they are used simultaneously, careful monitoring of the patient's condition by medical personnel is required.
3. Antacids containing magnesium and aluminum reduce the absorption period of CellCept.
4. Cholestyramine. Reduces AUC by up to forty percent when taking one and a half grams of CellCept after taking four grams three times a day, duration four days Cholestyramine.
5. Cyclosporine. Selsept does not affect Cyclosporine. But when taken together, the effect of MFC is reduced to 50%.
6. Oral contraceptives. CellCept does not affect. Although, when undergoing therapy with the drug, it is necessary to additionally use other methods of contraception.
7. Norfloxacin, Metronidazole. One antibacterial drug does not change the bioavailability of the drug. But a single dose of CellCept together with Norfloxacin and Metronidazole significantly reduces AUC (by thirty percent).
8. Rifampicin. When using drugs simultaneously, and simultaneous transplantation of lungs and kidneys, it is necessary to change the dose under the supervision of medical personnel.
9. Augmentin, Ciprofloxacin. With the combined use of CellCept and antibacterial therapy with these drugs, there is a decrease in the minimum concentration by 54%. Then, if the patient continues therapy, this effect decreases, and after the end of antibiotics, it disappears.
10. Tacrolimus: No effect, only in stable liver transplant patients AUC increases by twenty percent for Tacrolimus.
11. Calcium channel blockers. There is an increase in the density of MFCG.
12. Live vaccines. Cannot be used together with Selsept.

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Storage conditions

The medicine belongs to the category of potent drugs. Store in a dark place, inaccessible to children. Keep the temperature regime no more than 30°C.

Special instructions

Reviews

The drug has proven itself from the best side, it is widely used in various transplant clinics. It is prescribed to prevent acute organ rejection. Thanks to CellCept, the survival rate of patients after transplantation is significantly increased.

Shelf life

3 years.