Rapamune 1 mg Tablet (Sirolimus)

Adult dose

This medication is administered orally once daily. To minimize variability in exposure to this medication, administer it consistently either with food or on an empty stomach. Do not crush, chew, or cut this medication. 1. Usual dosage in kidney transplant patients The initial dose of this medication should be administered as soon as possible after transplantation. It is recommended that this medication be administered 4 hours after oral cyclosporine solution and/or cyclosporine capsules. Once the maintenance dose of this medication has been adjusted, maintain that dose for at least 7~14 days before readjusting the dose based on blood concentration monitoring. For most patients, the following equation may be used for dose adjustment: New dose of this medication = Current dose X (Target blood concentration / Current blood concentration) If a substantial increase in the trough blood concentration of this medication is desired, a loading dose should also be considered in addition to the new maintenance dose: Loading dose of this medication = 3 X (New maintenance dose - Current maintenance dose) The maximum daily dose of this medication should not exceed 40mg. If administration of the loading dose would result in a planned daily dose exceeding 40mg, administer the loading dose over 2 days. The trough concentration of this medication should be monitored at least 3-4 days after administration of the loading dose. 2. Kidney transplant patients at low or moderate immunologic risk Combination therapy of this medication with cyclosporine: It is recommended that this medication initially be administered in combination with cyclosporine and corticosteroids. New kidney transplant recipients should receive a loading dose 3 times the maintenance dose. For kidney transplant patients, an initial loading dose of 6mg/day and a maintenance dose of 2mg/day are recommended. Maintain sirolimus concentrations within the target range through therapeutic drug monitoring. Administration of this medication after withdrawal of cyclosporine: Withdrawal of cyclosporine is recommended 2~4 months after transplantation. At 2-4 months after transplantation, cyclosporine should be gradually discontinued over 4-8 weeks, and the dose of this medication should be adjusted to achieve a trough concentration of 16-24ng/mL (chromatographic method) during the first year after transplantation. Thereafter, the target blood concentration of this medication should be 12-20 ng/mL (chromatographic method). When cyclosporine is not administered, the dose of this medication needs to be increased approximately 4-fold. 3. Kidney transplant patients at high immunologic risk For patients at high immunologic risk, combination therapy with cyclosporine and corticosteroids is recommended for 12 months after transplantation. Patients receiving this medication in combination with cyclosporine should receive a loading dose of 15mg on the day of transplantation. Starting on day 2, a maintenance dose of 5mg should be administered. Measure the trough concentration on days 5-7 of treatment and adjust subsequent doses of this medication to achieve a trough blood concentration of 10-15ng/mL (chromatographic method). The initial dose of cyclosporine should be 7mg/kg/day in divided doses, and the dose should continue to be adjusted until the target whole-blood trough concentration is reached. The target whole-blood trough concentrations are 200-300ng/mL through day 14, 150-200ng/mL from day 15 to week 26, and 100-150ng/mL from week 27 to week 52. Prednisolone should be administered at a dose of at least 5mg/day. Antibody induction therapy may be used. 4. Dosage in patients with lymphangioleiomyomatosis The initial dose of this medication in patients with lymphangioleiomyomatosis is 2 mg once daily. The whole-blood trough concentration of this medication should be measured on days 10-20, and the dose should be adjusted to maintain the concentration within 5-15 ng/mL. For most patients, the following equation may be used for dose adjustment: New dose of this medication=Current doseX(Target blood concentration/Current blood concentration). Once the maintenance dose of this medication has been adjusted, maintain that dose for at least 7-14 days before readjusting the dose based on blood concentration monitoring. Once a stable dose has been established, therapeutic drug monitoring should be performed at least once every 3 months. 5. Dose adjustment For patients with mild to moderate hepatic impairment, it is recommended that the maintenance dose be approximately 2/3 of the dose for patients with normal hepatic function. For patients with severe hepatic impairment, it is recommended that the maintenance dose be approximately 1/2 of the dose for patients with normal hepatic function. No change to the loading dose is necessary. No dose adjustment is required in patients with renal impairment.

Child dose

For patients aged 13 years and older who weigh less than 40kg, adjust the initial loading dose to 3mg/m2/day and the maintenance dose to up to 1mg/m2/day based on body surface area.

This medication is used to suppress the immune system to prevent rejection after organ transplantation such as kidney transplants. Taking this medication may increase susceptibility to infections, and there is a rare risk of developing malignant tumors such as lymphomas or skin cancers. Its use is not recommended in patients with liver or lung transplants. In patients who have just received a liver transplant, the combined administration of this medication with other immunosuppressants may increase mortality and the risk of transplant failure. While taking this medication, blood cholesterol and triglyceride levels may rise, so regular blood tests should be conducted, and treatment may be necessary if indicated. Kidney function may decline, so kidney function tests should be performed regularly, and if kidney function worsens, adjustments in dosing should be discussed with a doctor. This medication can interact with other drugs, so it's important to inform healthcare providers about all medications being taken, as adjustments may be necessary. Particular caution is required when used in conjunction with certain antifungals, antibiotics, calcium channel blockers, and some herbal medicines. Women who are pregnant or planning to become pregnant should consult with a doctor before taking this medication and should use effective contraception. Breastfeeding women should also consult with healthcare professionals before taking this medication. This medication is not absorbed through the skin, but if it comes into direct contact with skin or eyes, it should be washed off immediately with clean water. Caution is also required when administering to children or the elderly, especially since safety in children under 13 years has not been established. Vaccination efficacy may be reduced, so live vaccines should be avoided, and appropriate preventative measures should be taken as directed by a physician to prevent infections. Overdose requires general treatment, and dialysis may not remove it, so prompt medical action is necessary. While taking this medication, regular checkups and strict adherence to healthcare provider's instructions are essential, and medical attention should be sought immediately for any unusual symptoms.

Increased susceptibility to infections, lymphoma, malignant tumors, lymphomas of the skin, opportunistic infections, sepsis, fatal infections, hepatic artery thrombosis, bronchial anastomotic dehiscence, thrombocytopenia, anemia, leukopenia, hemolytic uremic syndrome, neutropenia, pancytopenia, thrombotic thrombocytopenic purpura, tachycardia, pericardial effusion, abdominal pain, constipation, diarrhea, nausea, pancreatitis, stomatitis, ascites, healing disorders, edema, peripheral edema, fever, pain, hypersensitivity, pneumonia, fungal infections, viral infections, bacterial infections, herpes simplex, urinary tract infections, pyelonephritis, cytomegalovirus infection, shingles, mycobacterial infections, Epstein-Barr virus infection, abnormal liver function tests, increased serum creatinine, increased serum lactate dehydrogenase, hypokalemia, hypophosphatemia, hyperlipidemia, hyperglycemia, hypertriglyceridemia, fluid retention, diabetes, arthralgia, osteonecrosis, squamous cell carcinoma of the skin, basal cell carcinoma, malignant melanoma, post-transplant lymphoproliferative disorder, neuroendocrine carcinoma of the skin, headache, reversible posterior leukoencephalopathy syndrome, proteinuria, nephrotic syndrome, focal segmental glomerulosclerosis, menstrual disorders, ovarian cysts, pulmonary embolism, interstitial pneumonia, pleural effusion, epistaxis, pulmonary hemorrhage, pulmonary alveolar proteinosis, rash, acne, desquamative skin dermatitis, hypersensitivity vasculitis, hypertension, venous thrombosis, lymphedema, asthenia, abdominal distension, chills, cold symptoms, hernia, malaise, atrial fibrillation, congestive heart failure, hemorrhage, hypervolemia, hypotension, palpitations, peripheral vascular disorders, orthostatic hypotension, syncope, vasodilation, dyspepsia, vomiting, loss of appetite, dysphagia, belching, esophagitis, gastric distention, gingival hyperplasia, intestinal obstruction, oral candidiasis, Cushing's syndrome, diabetes, petechiae, leukocytosis, lymphadenopathy, polycythemia, hyperkalemia, weight gain, acidosis, increased BUN, increased creatine phosphokinase, dehydration, hypercalcemia, hypocalcemia, hyperphosphatemia, hypoglycemia, hypomagnesemia, hyponatremia, weight loss, arthrosis, leg cramps, myalgia, osteoporosis, stiffness, tremors, anxiety, confusion, depression, dizziness, emotional instability, muscle hypertonicity, sensory deficits, muscle hypotonia, insomnia, neuropathy, paresthesia, drowsiness, dyspnea, asthma, atelectasis, increased cough, hypoxemia, pulmonary edema, fungal dermatitis, hirsutism, pruritus, skin hypertrophy, skin ulcers, sweating, abnormal vision, cataracts, hearing loss, tinnitus, dysuria, hematuria, hydronephrosis, erectile dysfunction, renal colic, tubular necrosis, nocturia, oliguria, pyuria, testicular disorders, toxic nephropathy, increased urinary frequency, urinary incontinence, urinary retention, polyuria, local reaction to surgery, pneumonia, acute rejection reaction, transplant failure, death, azoospermia, Clostridium difficile small bowel colitis, liver necrosis, fasciitis, incisional hernia, anastomotic rupture, BK virus-associated nephropathy, progressive multifocal leukoencephalopathy, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, thrombotic microangiopathy, hypertension, cardiac hypertrophy, lymphorrhea, increased creatinine, acne, urinary system abnormalities, ovarian cysts, pain, fever, headache, tremor, insomnia, rhinitis, increased cough, renal tubular necrosis, hematuria, hypercholesterolemia, weight loss, fractures, cholangitis, vesicoureteral reflux, secondary hyperparathyroidism, contact dermatitis, polyomavirus infection, increased plasma osmolality, exacerbation of angina, cholangitis, renal artery occlusion, cavities, exacerbation of angina, ulcerative stomatitis, anaphylaxis, anaphylactic reaction, angioedema, desquamative dermatitis, hypersensitivity vasculitis, increased serum cholesterol, increased triglycerides, rhabdomyolysis, angioneurotic edema, angioneurotic edema type reactions

This medication should be stored in a tightly closed container to protect it from air and light, ideally kept at room temperature between 20 to 25 degrees Celsius away from direct sunlight.

Appearance

White, triangular film-coated tablet

Package unit

100 tablets (10 tablets/blister x 10)