Gengraf

1 What is Gengraf?

Brand: Gengraf, Neoral, SandIMMUNE

Generic: Cyclosporine

Gengraf is the most effective drug for prevention and treatment of graft rejection reaction. It is routinely used in renal, hepatic, cardiac, bone marrow, and other transplantations. For induction, it is started orally 12 hours before the transplant and continued for as long as needed.

Indeed, this is an immunosuppressant drug that selectively suppresses cell-mediated immunity (CMI), prevents graft rejection and yet leaves the recipient with enough immune activity to combat bacterial infection.

In addition, Gengraf is considered as a second line drug in autoimmune diseases, like severe rheumatoid arthritis, uveitis, bronchial asthma, inflammatory bowel disease, dermatomyositis, etc. and in psoriasis, especially to suppress acute exacerbations.

It is generally used along with corticosteroids or methotrexate. Good results have been obtained in some cases of aplastic anemia. However, it is not curative and relapses occur when the drug is withdrawn.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

  • Capsule
  • Capsule, Liquid Filled
  • Solution

2 What to Know Before Using

Before using Gengraf, you must know all about the risks and complications associated with it. The suitable drug therapy is usually chosen by a doctor with the active participation of the patient.

There are some important factors such as drug interactions, the presence of any metabolic impairment, history of hypersensitivity reaction, pregnancy, lactation etc. which may alter the desired therapeutic effects of a medicine.

Sometimes the presence of other health disorders affects the beneficial effects of this medicine and even may cause serious toxic effects. If you have had any allergic reactions to any medicine then you must tell your doctor about that.

The use of cyclosporine is contraindicated in those with known hypersensitivity, malignant neoplasms, and uncontrolled hypertension.

Make sure you inform your doctor if you have any other medical problems, especially:

  • Abnormal kidney function
  • Cancer
  • Hypertension (high blood pressure) – patients with rheumatoid arthritis who also have these conditions should not receive this medicine.
  • Alcohol abuse
  • Epilepsy (seizures)
  • Liver disease – this medicine contains alcohol, which can make these conditions worse.
  • Active infection
  • Anemia
  • Bleeding disorders
  • Brain disease (e.g., encephalopathy)
  • Eye or visual problems (e.g., papilloedema)
  • Hyperkalemia (high potassium in the blood)
  • Hyperuricemia (too much uric acid in the blood)
  • Precancerous skin changes
  • Thrombocytopenia (low number of platelets) – this drug may make these conditions worse.

Cyclosporine can interact with a large number of drugs. Because of drug-drug interactions, it is always recommended to consult with your doctor if you are in need of some other medications or even any over-the-counter medicine for another health problem in order to avoid unwanted toxic effects.

Besides, the following drug interactions should be kept in mind:

  • All nephrotoxic drugs like aminoglycosides, vancomycin, amphotericin B, ciprofloxacin, co-trimoxazole, and NSAIDs enhance its toxicity.
  • Phenobarbitone, phenytoin, carbamazepine, isoniazid, rifampicin, and other enzyme inducers lower its blood levels so that transplant rejection may result.
  • CYP3A4 inhibitors erythromycin, ketoconazole, and related drugs inhibit its metabolism to increase bioavailability and cause toxicity.
  • When this drug is concurrently used with high-dose methylprednisolone, there is increased the risk of convulsion.
  • Potassium supplements and potassium-sparing diuretics can produce marked hyperkalemia in patients on cyclosporine.
  • On the other hand, this drug may reduce excretion of many drugs by depressing renal function.

Animal reproduction studies have shown an adverse effect, and there are no adequate and well-controlled studies in pregnant women. Thus, this drug should be used during pregnancy only if clearly needed.

Besides, caution should be exercised when used in lactating women because there are no adequate studies in women for determining infant risk when using this medication during breastfeeding.

3 Proper Usage

To use Gengraf properly, you must follow all instructions given by your doctor. The dosage schedule and the duration of drug therapy should be individualized and determined based on the physician’s advice.

The therapeutic dose may also vary with the patient’s condition or requirement and the strength of the medicine as well; however, different dosages are listed below based on indications:

For prevention of transplant rejection:

  • Adults and children— Dose will be determined by your doctor (depends on the transplanted organ). Usually, 10-15 mg/kg/day are taken 4 to 12 hours before organ transplantation and continued for 1 to 2 weeks. Maintenance dose is considered in between 2-6 mg/kg/day. Lower doses may be used when combined with other immunosuppressants. Your doctor may adjust your dose as needed.

For treatment of severe atopic dermatitis and/or psoriasis:

  • Adults— Dose is based on body weight and must be determined by your doctor. The starting dose is usually 2.5 mg/kg/day, divided into two doses. The maximum therapeutic dose should not exceed 5 mg/kg/day. Your doctor may adjust your dose as needed.
  • Children— Use and dose must be determined by your doctor.

For treatment of rheumatoid arthritis:

  • Adults— Dose is based on body weight and must be determined by your doctor. The starting dose is usually 2.5 mg/kg/day, divided into two doses. Treatment should be continued for 6 to 8 weeks. The maximum therapeutic dose should not exceed 4 mg/kg/day. Your doctor may adjust your dose as needed.
  • Children— Use and dose must be determined by your doctor.

For treatment of nephrotic syndrome:

  • Adults— Dose is based on body weight and must be determined by your doctor. The usual dose is 5 mg/kg/day, divided into two doses. Your doctor may adjust your dose as needed.
  • Children— Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. But, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use this drug in larger amounts, more often, or for a longer time than your doctor ordered.

Further, it is advised to store the medicine in a closed container at room temperature away from heat, moisture, and direct light. All kinds of medicines should be kept out of the reach of children. However, outdated medicines should be disposed of by an appropriate way.

4 Precautions to Take

Before using Gengraf, there are some precautions you must take. Firstly, regular visits to your doctor are recommended to check that this medicine is working properly or not.

Additionally, the following guidelines should be followed to prevent unwanted complications as well as for the better prognosis of the patients: 

  • You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away.
  • Check with your doctor right away if you have any of the following symptoms:
    • blood in the urine,
    • change in the frequency of urination or amount of urine,
    • difficulty breathing,
    • drowsiness,
    • increased thirst,
    • loss of appetite,
    • nausea or vomiting, or swelling of the feet or lower legs, or weakness.

These may be symptoms of a serious kidney problem.

  • Do not use supplements or salt substitutes containing potassium without first checking with your doctor.
  • Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.
  • This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are using this medicine. Tell your doctor if you have any kind of infection before you start using this medicine. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
  • While you are being treated with cyclosporine, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Cyclosporine may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent.
  • In addition, you should not be around other persons living in your household who have received live virus vaccines recently because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella.
  • In some patients (usually younger patients), tenderness, swelling, or bleeding of the gums may appear soon after treatment with cyclosporine is started. Brushing and flossing your teeth, carefully and regularly, and massaging your gums may help prevent this. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.
  • This medicine may make your skin more sensitive to sunlight and can increase your risk of having skin cancer. If you are being treated for psoriasis, check with your doctor first before having an ultraviolet (UV) light treatment. Use a sunscreen when you are outdoors and avoid sunlamps and tanning beds.
  • This medicine may cause a serious nervous system problem. Tell your doctor right away if you have the following symptoms: confusion, loss of consciousness, mental changes, muscle weakness, seizures, or vision changes.
  • Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter) medicines and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Gengraf. These side effects usually go away during the treatment episode as your body adjusts to the medicine.

Your healthcare professional may advise you about the ways how to prevent or reduce those unwanted side effects.

Sometimes you may need to consult with the doctor if you notice any of the following toxic effects:

More common:

  • Abdominal or stomach pain or tenderness
  • Back pain
  • Black, tarry stools
  • Blurred vision
  • Chest pain
  • Chills
  • Cloudy or dark urine
  • Cough
  • Decrease in urine output
  • Decreased or loss of appetite
  • Dizziness
  • Drowsiness
  • Fever
  • A headache–may be severe and throbbing
  • Itching
  • Muscle spasms or twitching
  • Nausea and vomiting
  • Nervousness
  • Painful or difficult urination
  • Pounding in the ears
  • Shortness of breath
  • Skin rash
  • Slow or fast heartbeat
  • Sore throat
  • Sores, ulcers, or white spots on the lips or in the mouth
  • Swelling of the feet or lower legs
  • Swollen glands
  • Trembling or shaking of the hands or feet
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness
  • Yellowish discoloration of eyes or skin

Less common:

  • Bleeding gums
  • Blood in the urine
  • Blood in the vomit
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • Convulsions
  • Difficulty swallowing
  • Hives
  • Pale skin
  • Pinpoint red spots on the skin
  • Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • Severe or continuing stomach pain
  • Tightness in the chest
  • Troubled breathing with exertion

Rare:

  • Bloating
  • Chest discomfort
  • Constipation
  • Hoarseness
  • Indigestion
  • Night sweats
  • Pain or discomfort in the arms, jaw, back, or neck
  • Pains in the stomach, side, or abdomen, possibly radiating to the back
  • Vomiting of blood or material that looks like coffee grounds

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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