Cyclosporine 100mg/ml Mod Oral Soln

Manufacturer IVAX PHARMACEUTICALS, INC. Active Ingredient Cyclosporine Oral Solution, Modified(SYE kloe spor een) Pronunciation SYE kloe spor een
WARNING: You may have more of a chance of getting an infection. Some infections have been severe or deadly. Wash hands often. Stay away from people with infections, colds, or flu.Lymphoma and other cancers have happened in people who take this drug or drugs like it. This has been deadly in some cases. Talk with the doctor.If this drug is given with other drugs that work on the immune system, it can add to the chance of getting an infection or lymphoma or other cancers. Call your doctor right away if you have a change in color or size of a mole; a lump in the armpit, groin, or neck; or any new or changing skin lump or growth. Talk with the doctor.Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.This drug may cause kidney problems in some patients. Talk with the doctor. High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor.Have your blood work and other lab tests checked as you have been told by your doctor.There are different brands and forms of this drug. Do not switch between different brands or forms of this drug without calling the doctor who ordered it.If you are taking this drug for psoriasis AND you have used other drugs or radiation to treat this health problem before, your chance of skin cancer may be higher. @ COMMON USES: It is used to keep the body from harming the organ after an organ transplant.It is used to treat rheumatoid arthritis.It is used to treat psoriasis.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Immunosuppressant
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Pharmacologic Class
Calcineurin Inhibitor
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Pregnancy Category
C
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FDA Approved
Jun 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cyclosporine is a medicine that helps prevent your body from rejecting a transplanted organ (like a kidney, liver, or heart) by weakening your immune system. It can also be used to treat severe rheumatoid arthritis or psoriasis by calming down an overactive immune system. Because it weakens your immune system, it's very important to take it exactly as prescribed and be aware of potential side effects like kidney problems, high blood pressure, and increased risk of infections.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food, but be consistent in how you take it each time. Always take it with food or always take it on an empty stomach.
If you are also taking sirolimus, take it 4 hours after taking this medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Take your medication at the same time every day to establish a routine.

Measuring and Taking Liquid Doses

Measure your liquid doses carefully using the measuring device provided with your medication.
Do not rinse the syringe before or after taking your dose. If you need to wash it, make sure it is completely dry before using it again.
To take your medication, mix the solution with orange or apple juice at room temperature in a glass. Drink the mixture immediately.
Rinse the glass with more liquid and drink to ensure you get the full dose.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from refrigeration and freezing.
Keep your medication in its original container to maintain its potency.
Discard any unused portion of your medication 2 months after opening the container.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take cyclosporine at the same time each day, consistently with or without food, to maintain stable blood levels.
  • Do not switch between different brands or formulations of cyclosporine without consulting your doctor, as they are not interchangeable.
  • Avoid grapefruit and grapefruit juice, as they can significantly increase cyclosporine levels and lead to toxicity.
  • Avoid St. John's Wort, as it can significantly decrease cyclosporine levels and lead to organ rejection.
  • Limit exposure to sunlight and UV light, and use sunscreen and protective clothing, due to increased risk of skin cancer.
  • Avoid live vaccines while on cyclosporine.
  • Report any signs of infection (fever, chills, sore throat) immediately to your doctor.
  • Maintain good oral hygiene to help prevent gingival overgrowth.
  • Regularly monitor blood pressure at home if advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on indication, patient response, and therapeutic drug monitoring (TDM) of trough levels. Dosing is typically initiated at higher levels post-transplant and then tapered.
Dose Range: 2 - 15 mg

Condition-Specific Dosing:

kidneyTransplant: Initial: 7-9 mg/kg/day orally in two divided doses. Maintenance: 3-6 mg/kg/day.
liverTransplant: Initial: 8-10 mg/kg/day orally in two divided doses. Maintenance: 4-8 mg/kg/day.
heartTransplant: Initial: 10-15 mg/kg/day orally in two divided doses. Maintenance: 5-10 mg/kg/day.
rheumatoidArthritis: Initial: 2.5 mg/kg/day orally in two divided doses. Max: 4 mg/kg/day.
psoriasis: Initial: 2.5 mg/kg/day orally in two divided doses. Max: 5 mg/kg/day.
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Pediatric Dosing

Neonatal: Not established, use with extreme caution and TDM.
Infant: Dosing is highly individualized based on weight, age, and indication, similar to adult mg/kg dosing but with careful TDM. Typically 5-10 mg/kg/day in two divided doses for transplant prophylaxis.
Child: Dosing is highly individualized based on weight, age, and indication, similar to adult mg/kg dosing but with careful TDM. Typically 5-10 mg/kg/day in two divided doses for transplant prophylaxis.
Adolescent: Dosing is highly individualized based on weight, age, and indication, similar to adult mg/kg dosing but with careful TDM. Typically 5-10 mg/kg/day in two divided doses for transplant prophylaxis.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment for mild impairment, but monitor renal function closely and adjust dose to maintain target trough levels and avoid nephrotoxicity.
Moderate: Reduce dose by 25-50% or extend dosing interval. Monitor renal function and cyclosporine trough levels closely. Consider alternative immunosuppressants if renal function continues to decline.
Severe: Significant dose reduction (e.g., 50% or more) or discontinuation may be necessary. Monitor renal function and cyclosporine trough levels very closely. Use with extreme caution.
Dialysis: Cyclosporine is not significantly removed by hemodialysis or peritoneal dialysis. Dose adjustment is based on residual renal function and trough levels, not dialysis schedule.

Hepatic Impairment:

Mild: No specific dose adjustment, but monitor cyclosporine trough levels and liver function tests closely.
Moderate: Reduce initial dose by 25-50% and monitor cyclosporine trough levels closely. Further adjustments based on TDM and clinical response.
Severe: Reduce initial dose by 50-75% or more. Monitor cyclosporine trough levels and liver function tests very closely. Use with extreme caution due to impaired metabolism and increased risk of toxicity.

Pharmacology

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Mechanism of Action

Cyclosporine is a calcineurin inhibitor. It forms a complex with cyclophilin (an intracellular immunophilin). This complex then inhibits calcineurin, a calcium-dependent phosphatase. Inhibition of calcineurin prevents the dephosphorylation of the nuclear factor of activated T-cells (NF-AT), which is required for its translocation into the nucleus. This, in turn, inhibits the transcription of various cytokine genes, including interleukin-2 (IL-2), which is crucial for T-lymphocyte activation and proliferation. The net effect is a potent immunosuppressive action, primarily affecting cell-mediated immunity.
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Pharmacokinetics

Absorption:

Bioavailability: 20-50% (modified formulation has more consistent and higher bioavailability than non-modified)
Tmax: 1.5-2 hours
FoodEffect: Food can delay and decrease absorption, especially high-fat meals. Consistent administration relative to meals (e.g., always with food or always without) is recommended to minimize variability.

Distribution:

Vd: 3.5-5 L/kg
ProteinBinding: 90-98% (primarily to lipoproteins and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 8-24 hours (highly variable, depends on patient population and liver function)
Clearance: 0.4-0.7 L/hr/kg
ExcretionRoute: Primarily biliary/fecal (approximately 6% renal excretion)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Immunosuppressive effects begin within hours of administration, but full therapeutic effect for transplant prophylaxis is achieved with consistent dosing and therapeutic trough levels.
PeakEffect: Correlates with peak blood concentrations (Tmax), but clinical immunosuppression is a sustained effect.
DurationOfAction: Related to half-life and sustained trough levels; effects persist as long as therapeutic concentrations are maintained.

Safety & Warnings

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BLACK BOX WARNING

Cyclosporine (modified) should be administered under the supervision of a physician experienced in immunosuppressive therapy and management of organ transplant patients. Increased risk of serious infections and development of neoplasms (lymphoma, skin cancer). Increased risk of nephrotoxicity and hypertension. The modified formulation has increased bioavailability compared to the non-modified formulation (Sandimmune) and cannot be used interchangeably without physician supervision and monitoring of cyclosporine blood concentrations.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain
Signs of electrolyte problems: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting
Unexplained bruising or bleeding
Feeling extremely tired or weak
Abnormal burning, numbness, or tingling sensations
Chest pain or pressure, or a rapid heartbeat
Gum changes
Hearing loss
Shortness of breath
Shakiness
Swelling
Mouth irritation or mouth sores
Liver problems: dark urine, fatigue, decreased appetite, nausea, stomach pain, pale stools, vomiting, or yellowing of the skin and eyes (these can be fatal, so seek help immediately)
Progressive multifocal leukoencephalopathy (PML), a severe brain problem: confusion, memory problems, depression, changes in behavior, uneven strength, speech or thinking difficulties, balance problems, or vision changes (can cause disability or be fatal)
Posterior reversible encephalopathy syndrome (PRES), a severe brain problem: confusion, decreased alertness, vision changes, loss of vision, seizures, or severe headache (seek help immediately)

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild ones, others may have more bothersome symptoms. If you experience any of the following, contact your doctor or seek medical help:

Headache
Dizziness or drowsiness
Stomach pain or diarrhea
Nausea or vomiting
Gas
Hair growth
Acne
Flushing
Common cold symptoms
Joint pain
Leg cramps

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Fever, chills, sore throat, body aches (signs of infection)
  • Unusual tiredness or weakness
  • Swelling in hands, feet, or ankles; decreased urination (signs of kidney problems)
  • Yellowing of skin or eyes, dark urine, persistent nausea/vomiting, severe stomach pain (signs of liver problems)
  • Headache, tremor, seizures, confusion, numbness or tingling (signs of neurotoxicity)
  • Unusual bruising or bleeding
  • New skin lesions or changes in existing moles
  • Significant increase in blood pressure
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the symptoms you experienced during an allergic reaction.
Certain health conditions, including:
+ Cancer
+ Kidney problems
+ High blood pressure
Other medications you are taking, such as:
+ Aliskiren
+ Amiloride
+ Bosentan
+ Dabigatran
+ Orlistat
+ Spironolactone
+ Triamterene
If you have psoriasis and are undergoing other treatments, including medications or radiation therapy.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status.

To ensure your safety, do not start, stop, or modify the dosage of any medication without consulting your doctor. This medication can interact with numerous other drugs, increasing the risk of severe, life-threatening, or fatal side effects. Therefore, it is vital to verify the safety of taking this medication with all your other treatments and health conditions.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in activities that require alertness, ensure you understand how this medication affects you.

If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this drug.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or any potassium product, consult your doctor to discuss potential interactions.

This medication contains alcohol, so it is important to discuss this with your doctor.

There may be an increased risk of skin cancer associated with this medication. To minimize this risk, limit your exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear. Regular skin checks, as advised by your doctor, are also necessary.

In rare cases, this medication has been linked to severe kidney problems caused by the BK virus, particularly in individuals who have undergone a kidney transplant. This infection can lead to loss of the transplanted kidney. If you have concerns, consult your doctor.

Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

Maintaining good oral hygiene is important; schedule regular dental check-ups to ensure the health of your teeth.

Avoid consuming grapefruit and grapefruit juice while taking this medication.

Be aware of the potential for gout attacks and monitor your condition accordingly.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

For pediatric patients, this medication should be used with caution, as the risk of certain side effects may be higher in children.

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately.

If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Severe nephrotoxicity (acute renal failure)
  • Hepatotoxicity
  • Neurotoxicity (tremor, seizures, coma)
  • Severe hypertension
  • Nausea, vomiting, abdominal pain

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is primarily supportive and symptomatic. Cyclosporine is not dialyzable to a significant extent.

Drug Interactions

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Contraindicated Interactions

  • Bosentan (increased cyclosporine levels, increased bosentan toxicity)
  • Aliskiren (increased cyclosporine levels, increased aliskiren toxicity)
  • Dabigatran (increased dabigatran levels, increased bleeding risk)
  • Live attenuated vaccines (due to immunosuppression)
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Major Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, diltiazem, verapamil, grapefruit juice) - significantly increase cyclosporine levels.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) - significantly decrease cyclosporine levels.
  • Nephrotoxic agents (e.g., NSAIDs, aminoglycosides, amphotericin B, tacrolimus, sirolimus, ACE inhibitors, ARBs) - increased risk of nephrotoxicity.
  • Potassium-sparing diuretics, ACE inhibitors, ARBs (increased risk of hyperkalemia).
  • Statins (e.g., atorvastatin, simvastatin) - increased risk of myopathy/rhabdomyolysis due to increased statin levels.
  • Colchicine (increased colchicine toxicity).
  • Digoxin (increased digoxin levels).
  • Immunosuppressants (e.g., tacrolimus, sirolimus, everolimus) - increased risk of profound immunosuppression and toxicity.
  • Nefazodone (increased cyclosporine levels).
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Moderate Interactions

  • Oral contraceptives (may increase cyclosporine levels slightly).
  • Metoclopramide (may increase cyclosporine levels).
  • Allopurinol (may increase cyclosporine levels).
  • Cimetidine (may increase cyclosporine levels).
  • Danazol (may increase cyclosporine levels).
  • Methotrexate (increased risk of hepatotoxicity).
  • Vaccines (reduced efficacy of vaccines).
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Minor Interactions

  • Magnesium-containing antacids (may decrease cyclosporine absorption if taken concurrently).

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., anemia, leukopenia).

Timing: Prior to initiation

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To establish baseline renal function and monitor for cyclosporine-induced nephrotoxicity.

Timing: Prior to initiation

Liver Function Tests (ALT, AST, ALP, Bilirubin)

Rationale: To establish baseline liver function and monitor for hepatotoxicity.

Timing: Prior to initiation

Blood Pressure

Rationale: To establish baseline and monitor for hypertension, a common side effect.

Timing: Prior to initiation

Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)

Rationale: To establish baseline and monitor for hyperlipidemia.

Timing: Prior to initiation

Electrolytes (Potassium, Magnesium)

Rationale: To establish baseline and monitor for hyperkalemia and hypomagnesemia.

Timing: Prior to initiation

Uric Acid

Rationale: To establish baseline and monitor for hyperuricemia.

Timing: Prior to initiation

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Routine Monitoring

Cyclosporine Trough Levels (C0 or C2)

Frequency: Initially 2-3 times per week, then weekly, then every 2-4 weeks, then monthly or as clinically indicated.

Target: Highly variable based on indication, time post-transplant, and concomitant immunosuppression (e.g., 100-400 ng/mL for C0 in transplant, 50-150 ng/mL for C0 in autoimmune diseases). C2 levels may be used in some centers.

Action Threshold: Adjust dose to maintain target range; levels outside range may indicate toxicity or sub-therapeutic dosing.

Renal Function (BUN, Serum Creatinine)

Frequency: Initially 2-3 times per week, then weekly, then every 2-4 weeks, then monthly or as clinically indicated.

Target: Maintain within acceptable limits for the patient's baseline.

Action Threshold: Increase in serum creatinine >25% from baseline or significant decline in eGFR warrants dose reduction or investigation.

Liver Function Tests (ALT, AST, ALP, Bilirubin)

Frequency: Initially weekly, then every 2-4 weeks, then monthly or as clinically indicated.

Target: Within normal limits.

Action Threshold: Significant elevation warrants dose reduction or investigation.

Blood Pressure

Frequency: Daily initially, then weekly, then monthly.

Target: <130/80 mmHg (or as per clinical guidelines).

Action Threshold: Sustained hypertension requires antihypertensive therapy or cyclosporine dose adjustment.

Electrolytes (Potassium, Magnesium)

Frequency: Initially weekly, then every 2-4 weeks, then monthly or as clinically indicated.

Target: Potassium: 3.5-5.0 mEq/L; Magnesium: 1.5-2.5 mg/dL.

Action Threshold: Hyperkalemia or hypomagnesemia requires intervention (e.g., supplementation, dietary changes, medication adjustment).

Lipid Profile

Frequency: Every 3-6 months.

Target: As per cardiovascular risk guidelines.

Action Threshold: Dyslipidemia requires lifestyle modification or lipid-lowering therapy.

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, unusual fatigue)
  • Signs of kidney problems (decreased urine output, swelling in legs/feet, unusual weight gain)
  • Signs of liver problems (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, abdominal pain)
  • Headache, tremor, seizures, confusion, visual disturbances (neurotoxicity)
  • Gingival overgrowth, hirsutism
  • Muscle pain or weakness
  • Unusual bruising or bleeding
  • Skin changes (new moles, lesions, or changes in existing ones)

Special Patient Groups

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Pregnancy

Cyclosporine is Pregnancy Category C. It crosses the placenta. While data from human pregnancies suggest no increased risk of major birth defects, there is an increased risk of prematurity and low birth weight. Use only if the potential benefit justifies the potential risk to the fetus. Close monitoring of cyclosporine levels and maternal/fetal health is essential.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations based on available human data. However, immunosuppression during organogenesis is a concern.
Second Trimester: Continued risk of prematurity and low birth weight. Close monitoring of maternal cyclosporine levels and fetal growth.
Third Trimester: Continued risk of prematurity and low birth weight. Potential for neonatal immunosuppression, though typically transient.
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Lactation

Cyclosporine is excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., immunosuppression, nephrotoxicity, increased risk of malignancy), breastfeeding is not recommended during cyclosporine therapy.

Infant Risk: High (L4)
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Pediatric Use

Dosing is weight-based and highly individualized, requiring careful therapeutic drug monitoring (TDM) due to variable pharmacokinetics. Children may require higher mg/kg doses than adults due to faster metabolism. Increased risk of lymphoproliferative disorders and other malignancies in pediatric transplant recipients.

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Geriatric Use

No specific dose adjustments are typically required based solely on age, but geriatric patients may have age-related declines in renal or hepatic function, which necessitate dose adjustments and closer monitoring. They may also be more susceptible to adverse effects like hypertension and nephrotoxicity. Start at the lower end of the dosing range and titrate carefully with TDM.

Clinical Information

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Clinical Pearls

  • Always specify 'modified' or 'non-modified' cyclosporine as they are not bioequivalent and cannot be interchanged without dose adjustment and close monitoring.
  • Therapeutic drug monitoring (TDM) of cyclosporine trough levels (C0 or C2) is crucial for safe and effective dosing.
  • Grapefruit and St. John's Wort are absolute contraindications due to significant drug interactions.
  • Nephrotoxicity is the most common and dose-limiting side effect; monitor renal function closely.
  • Hypertension is common and often requires antihypertensive therapy.
  • Increased risk of infections and malignancies (especially skin cancer and lymphoproliferative disorders) requires patient education and vigilance.
  • Gingival hyperplasia and hirsutism are common cosmetic side effects that can impact adherence.
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Alternative Therapies

  • Tacrolimus (another calcineurin inhibitor, often preferred due to lower incidence of cosmetic side effects and potentially better efficacy in some settings)
  • Sirolimus (mTOR inhibitor)
  • Everolimus (mTOR inhibitor)
  • Mycophenolate Mofetil (antiproliferative agent)
  • Azathioprine (antiproliferative agent)
  • Corticosteroids (e.g., Prednisone)
  • Belatacept (selective T-cell costimulation blocker)
  • Rituximab (anti-CD20 monoclonal antibody for autoimmune conditions)
  • Methotrexate (for rheumatoid arthritis, psoriasis)
  • Biologic DMARDs (e.g., TNF inhibitors for rheumatoid arthritis, psoriasis)
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Cost & Coverage

Average Cost: $500 - $1500+ per 50 mL bottle (100 mg/mL)
Generic Available: Yes
Insurance Coverage: Tier 3 or 4 (Specialty Drug)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.