Cyclosporine

Sandimmune

Sandimmune, a brand of cyclosporine, is used primarily to prevent organ rejection post-transplant and to treat autoimmune conditions like rheumatoid arthritis and psoriasis. It suppresses the immune system, particularly by inhibiting lymphocyte activity and reducing interleukin-2 production. Available in oral capsules, solutions, and intravenous formulations, Sandimmune must be dosed carefully under medical supervision due to its complex interactions with other medications and its significant side effects, including potential kidney and liver damage. It’s also essential to monitor its blood levels to avoid toxicity.

Product Overview

Sandimmune, the brand name for cyclosporine, is a critical medication in transplant medicine and autoimmune disease management. It dampens the immune system’s activity, primarily by curtailing the action of T cells and the production of interleukin-2 (IL-2), a key regulator of white blood cells. This suppression helps prevent the body from rejecting transplanted organs and reduces the symptoms of autoimmune disorders such as rheumatoid arthritis and psoriasis.

The medication is available in various forms, including soft gelatin capsules, oral solutions, and intravenous formulations. The dosing of Sandimmune is highly specific and varies based on the type of transplant, the formulation used, and the presence of other medications. For example, the initial oral dose for a kidney transplant may differ significantly from that for a liver or heart transplant.

Managing Sandimmune therapy is complex due to its interaction with numerous drugs, including NSAIDs, antifungals, antibiotics, and medications used for controlling blood pressure and cholesterol, which can either increase toxicity or reduce the effectiveness of Sandimmune. Moreover, side effects like kidney damage, hypertension, and liver dysfunction necessitate careful monitoring and management. It’s crucial for patients on Sandimmune to adhere strictly to prescribed doses and to consult healthcare providers regarding any other medications they are taking. Regular monitoring of drug levels in the blood is also essential to mitigate risks of toxicity and ensure therapeutic effectiveness. The drug’s use in children and seniors requires adjusted dosing to account for different metabolism rates and organ function.

What Are the Uses of Sandimmune?

Sandimmune is a medication designed to lower the activity of the immune system. It is primarily used to:

• Treat autoimmune diseases
• Prevent organ rejection

What Are the Forms & Strengths of Sandimmune?

This medication is available in the form of Soft Gelatin Capsules (cyclosporine capsules) and has the following strengths:

• Sandimmune 25 mg capsule
• Sandimmune 100 mg capsule

What Are the Recommended Dosage of Sandimmune

Usual Adult Dose for Psoriasis Using Oral Formulation (Modified)

Initial Dose:

• Amount: 1.25 mg/kg taken orally twice a day.
• Duration: Continue for at least 4 weeks.

Titration (Dose Adjustment):

• Condition for Increase: If there is no sufficient improvement after 4 weeks and the initial dose is well-tolerated,
• Adjustment Schedule: Increase the dose by 0.5 mg/kg/day every 2 weeks based on the patient’s response.
• Maximum Dose: Up to 4 mg/kg/day, divided into two doses.
• Note: Doses lower than 2.5 mg/kg/day might also be effective.

Monitoring and Adjustments:

• Adverse Events: If side effects occur (such as high blood pressure or significant increases in serum creatinine, 25% above the baseline), reduce the dose by 25% to 50%.
• Maintenance: Once stabilized, reduce to the lowest effective dose to maintain control of symptoms.

Usual Adult Dose for Organ Transplant – Rejection Prophylaxis

Oral Formulation (Modified):

• Timing: The initial dose should be administered between 4 to 12 hours before or after the transplant surgery.
• Dosage by Organ Type:
  • Kidney Transplant: 9 mg/kg/day, divided into two doses, with an adjustment range of plus or minus 3 mg/kg/day.
  • Liver Transplant: 8 mg/kg/day, divided into two doses, with an adjustment range of plus or minus 4 mg/kg/day.
  • Heart Transplant: 7 mg/kg/day, divided into two doses, with an adjustment range of plus or minus 3 mg/kg/day.
• Adjustments: The dose may be adjusted based on how well the organ transplant is accepted and the patient’s tolerance to the medication.

Oral Formulation (Non-Modified):

• General Guidance: This formulation has less bioavailability compared to the modified version, so dosing may differ.
• Initial Dose: Typically, 15 mg/kg is given orally 4 to 12 hours before the transplant. Clinical practice often uses 10 to 14 mg/kg/day for kidney transplants.
• Maintenance Dose: Start with the initial dose postoperatively for 1 to 2 weeks, then decrease by 5% per week to maintain a dose between 5 to 10 mg/kg/day.

Parenteral Formulation:

• Initial Dose: 5 to 6 mg/kg/day intravenously, which is about one-third of the oral dose, infused over 2 to 6 hours, administered 4 to 12 hours before the transplant.
• Maintenance Dose: Continue the IV dose postoperatively until oral intake is feasible.

Usual Pediatric Dose for Organ Transplant – Rejection Prophylaxis

Oral Formulation (Modified) for Children Aged 1 Year and Older:

• Initial Dose Timing: Administer 4 to 12 hours before or after the transplant surgery.
• Dosing by Organ Type:
  • Kidney Transplant: 9 mg/kg/day, divided into two doses (range adjustment: plus or minus 3 mg/kg/day).
  • Liver Transplant: 8 mg/kg/day, divided into two doses (range adjustment: plus or minus 4 mg/kg/day).
  • Heart Transplant: 7 mg/kg/day, divided into two doses (range adjustment: plus or minus 3 mg/kg/day).
• Dose Adjustments: Adjust the dosage based on how well the organ is accepted and the patient’s tolerance of the medication.
• Maintenance Therapy: Lower doses of the modified formulation may be effective for ongoing treatment.
• Additional Treatment: Initial therapy with adrenal corticosteroids is recommended.

Oral Formulation (Non-Modified) for Children Aged 6 Months and Older:

• Note: This formulation has a lower bioavailability than the modified version and should be used following specific local medical advice.
• Initial Dose: 15 mg/kg orally, administered 4 to 12 hours before transplantation, although doses between 10 to 14 mg/kg/day are commonly used for kidney transplants.
• Maintenance Dose: Continue the initial dose for 1 to 2 weeks post-surgery, then gradually reduce by 5% per week to a maintenance dose of 5 to 10 mg/kg/day.

Parenteral Formulation for Children Aged 6 Months and Older:

• Initial Dose: 5 to 6 mg/kg/day IV, infused over 2 to 6 hours and given 4 to 12 hours prior to transplantation.
• Maintenance Dose: Continue the IV dose postoperatively until the child can tolerate oral capsules or solution.

Usual Adult Dose for Rheumatoid Arthritis Using Oral Formulation (Modified)

Initial Dose:

• Amount: 1.25 mg/kg taken orally twice a day.
• Effectiveness Timeline: The effects of the medication usually start to become apparent between 4 and 8 weeks.

Titration (Dose Adjustment):

• Condition for Increase: If the initial dose does not provide sufficient relief and is well-tolerated (with serum creatinine levels remaining less than 30% above the baseline),
• Adjustment Schedule: The dose can be increased by 0.5 to 0.75 mg/kg/day after 8 weeks, and potentially again after 12 weeks.
• Maximum Dose: Up to 4 mg/kg/day, divided into two doses. If no improvement is observed by 16 weeks, the treatment should be discontinued.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Use Sandimmune?

• The dosage of Sandimmune that your doctor recommends will be tailored based on several important factors:
  • Type and Severity of Your Condition
  • Age
  • Form of Medication
  • Other Health Conditions
• Dosage Adjustments:
  • Initially, your doctor will likely start you on a lower dose of Sandimmune and adjust it gradually to find the optimal amount that effectively manages your condition without causing unnecessary side effects.
  • The goal is to prescribe the lowest dose that still achieves the desired therapeutic effect.
• Consequences of Not Following Prescribed Dosage:
  • If you miss doses or don’t take it on schedule: This could also lead to organ rejection or a resurgence of symptoms, potentially leading to serious health complications.
  • If you stop taking Sandimmune: There’s a risk that your body could reject a transplanted organ, or the symptoms of your RA or psoriasis could worsen or return.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Sandimmune Work?

Sandimmune works by suppressing the function of the immune system. Specifically, it decreases the activity of specific immune system cells known as lymphocytes, which include T helper cells and T suppressor cells. Additionally, Sandimmune reduces the production of an enzyme called interleukin-2 (IL-2), which is crucial for regulating the activity of white blood cells. By lowering IL-2 levels, Sandimmune diminishes the overall immune response of the body. This reduction in immune activity helps alleviate the symptoms associated with autoimmune diseases, where the body mistakenly attacks its own tissues.

Important Safety Information for Using Sandimmune

What Are the Side Effects of Sandimmune?

Common Side Effects of Sandimmune: This drug can cause side effects, which are usually temporary and last from a few days to a few weeks. If these side effects persist longer than expected, become bothersome, or intensify, it is essential to seek advice from your doctor or pharmacist. Some of the common side effects associated with Sandimmune include:

• Stomach pain
• Hair growth in certain areas
• Blood clots in your kidneys
• Acne
• High blood pressure
• Tremors
• Low magnesium levels in your body
• Increased size of your gums
• Headache

Serious Side Effects of Sandimmune: While taking Sandimmune, you may encounter serious side effects. The list provided here does not encompass all potential severe side effects of the medication. If you experience any serious side effects, it is crucial to contact your doctor immediately. In cases where the side effects seem life-threatening, or if you believe you are experiencing a medical emergency, call 911 or your local emergency number without delay. Serious side effects of Sandimmune may include:

• Kidney damage. Signs can include:
  • Blood in urine
• Liver damage. Signs can include:
  • Yellowing of your skin or the whites of your eyes
  • Pain in your upper abdomen
  • Pale stools
  • Dark urine
  • Blood in urine
• Lung problems. Signs can include:
  • Trouble breathing
• Heart problems. Signs can include:
  • Swelling of your feet or lower legs

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Are There Any Warnings for Sandimmune? 

• High Potassium Levels Warning: Sandimmune may increase the potassium levels in your blood. Elevated potassium can have profound health implications.
• Liver Damage Warning: There is a risk of liver damage or even liver failure when taking Sandimmune, particularly at high doses. This condition can be severe and potentially fatal.
• Food Interactions Warning: You should avoid consuming grapefruit or grapefruit juice while taking Sandimmune. Grapefruit products can enhance the absorption of Sandimmune, leading to higher levels of the medication in your body, which may increase the risk of side effects.

What Are the FDA Boxed Warning for Sandimmune?

Below are the Boxed Warnings given by the FDA for Sandimmune:

• High Blood Pressure and Kidney Disease: This medication can cause high blood pressure and kidney disease, which may require careful monitoring and management.
• Skin Disease: If you suffer from psoriasis and have received treatments such as psoralen plus ultraviolet A therapy, methotrexate, coal tar, radiation therapy, or ultraviolet light therapy, taking Sandimmune may increase your likelihood of developing additional skin diseases.
• Experienced Physician: Sandimmune should only be prescribed by healthcare providers who are experienced in managing systemic immunosuppressive therapy. This type of therapy is used for treating autoimmune diseases, where the immune system attacks the body’s own tissues.
• Infection: Sandimmune can significantly increase your risk of developing serious infections. It also raises the possibility of developing tumors or skin cancer.
• Gengraf and Neoral: Gengraf and Neoral, which are modified forms of cyclosporine, have better absorption than the non-modified Sandimmune capsules and oral solution. These versions should not be used interchangeably without proper medical supervision due to differences in absorption.
• Bioavailability: The absorption of Sandimmune, particularly in non-modified capsules and oral solutions, can become unpredictable with long-term use. Regular monitoring of blood levels of Sandimmune is recommended to avoid toxicity and potential organ rejection.

What Are the Sandimmune Precautions?

For People with Some Medical Conditions:

• Kidney and Liver Disorders: If you have existing kidney or liver issues, using Sandimmune could potentially worsen these conditions. Particularly, high doses of Sandimmune pose a greater risk of exacerbating kidney and liver disease.
• Serious Infections: Taking Sandimmune can heighten your risk of contracting severe viral infections, including polyomavirus infection. Such infections can be extremely serious and may even lead to fatal outcomes. It’s crucial to monitor for signs of infection and seek medical attention promptly if symptoms arise.

For Breastfeeding Women:

• Sandimmune can pass into breast milk and may harm a nursing baby. Discuss with your doctor whether to continue breastfeeding or take Sandimmune.
• Note that brand-name Sandimmune capsules contain ethanol, which can also pass through breast milk and negatively affect a breastfed child.

For Pregnant Women:

• If you are pregnant or planning to become pregnant, discuss with your doctor whether you should use Sandimmune. It should only be used if the benefits outweigh the potential risks to the unborn baby.
• Sandimmune is classified as a Category C pregnancy drug. Animal studies have shown harmful effects on the fetus, but human studies are insufficient to determine the risk to the fetus fully.

For Children:

• Post-Transplant: Children aged 6 months and older who have received kidney, liver, or heart transplants and are treated with Sandimmune typically do not experience unusual side effects.
• Rheumatoid Arthritis or Psoriasis: Sandimmune has not been proven safe or effective for children under 18 years old with rheumatoid arthritis or psoriasis.

For Seniors (65 years and older):

• Older adults are more prone to develop high blood pressure when using Sandimmune. Age-related decreases in liver and kidney function may also affect how the drug is processed in the body.
• To reduce the risk of kidney damage, your doctor might start you on a lower dose.

What If You Missed a Dose of Sandimmune?

If you miss a dose of Sandimmune, take it as soon as you remember. If it is almost time for your next dose, however, just skip the missed dose. Do not take two doses simultaneously to compensate for the missed dose, which could lead to dangerous side effects.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

What Happens If You Take Too Much of Sandimmune?

Taking too much Sandimmune can be harmful, leading to dangerously high levels of the drug in your body. Signs of an overdose may include:

• Yellowing of your skin or the whites of your eyes
• Swelling in your arms, hands, feet, ankles, or lower legs.

If you believe you have overdosed, contact your doctor immediately or call the American Association of Poison Control Centers at 800-222-1222. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

How to Store a Sandimmune?

Sandimmune should be stored at room temperature, between 68°F and 77°F (20°C and 25°C). Keep the medication away from light and high temperatures. Do not store it in damp or moist areas, such as bathrooms, to ensure it maintains its effectiveness.

[Note: Discuss with your healthcare professional the proper disposal of unused medicine and any questions you may have regarding its storage.]

What Medications Interact with Sandimmune?

Sandimmune can interact with various medications, potentially affecting how well it works or increasing side effects. Always inform your doctor and pharmacist about all medications you are taking, including prescription drugs, over-the-counter products, vitamins, herbs, and supplements. This is crucial to avoid any harmful interactions. Here are some specific examples:

• Antibiotics:
  • Decreased Sandimmune Levels: Antibiotics like nafcillin and rifampin can reduce Sandimmune levels, potentially leading to organ rejection if used for transplant rejection prophylaxis.
  • Increased Risk of Kidney Damage: Some antibiotics, such as ciprofloxacin, gentamicin, tobramycin, trimethoprim/sulfamethoxazole, and vancomycin, can increase the risk of kidney damage when taken with Sandimmune.
  • Increased Sandimmune Levels: Antibiotics such as azithromycin, clarithromycin, erythromycin, and quinupristin/dalfopristin may raise Sandimmune levels in your body, increasing side effects.
• Antifungals: Antifungals like amphotericin B, ketoconazole, fluconazole, itraconazole, and voriconazole can raise Sandimmune levels, possibly increasing side effects. Terbinafine may decrease Sandimmune levels, risking organ rejection.
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drugs such as ibuprofen, sulindac, naproxen, and diclofenac may increase the risk of kidney damage when taken with Sandimmune.
• Acid Reflux Drugs: Drugs like cimetidine may increase the risk of kidney damage when used with Sandimmune.
• Immunity-Suppressing Drugs: Taking tacrolimus with Sandimmune can heighten the risk of kidney damage.
• Birth Control Drugs: Contraceptive drugs may increase Sandimmune levels, leading to side effects.
• High Cholesterol Drugs: Cholesterol medications like fenofibrate and gemfibrozil can increase the risk of kidney damage. Other cholesterol-lowering drugs like atorvastatin, simvastatin, lovastatin, pravastatin, and fluvastatin may increase drug concentrations, causing muscle pain and weakness.
• Corticosteroids: Taking methylprednisolone with Sandimmune may increase its levels, leading to side effects.
• Blood Pressure Drugs: Drugs like diltiazem, nicardipine, and verapamil can increase Sandimmune levels in your body, possibly causing harmful effects.
• Anticonvulsants: Drugs like carbamazepine, oxcarbazepine, phenobarbital, and phenytoin may reduce Sandimmune levels, which could lead to organ rejection.
• Gout Drugs: Allopurinol and colchicine can increase Sandimmune levels or risk of kidney damage.
• Herbal Supplements: St. John’s wort can decrease Sandimmune levels, potentially causing organ rejection.
• HIV Drugs: Protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir may necessitate a dose adjustment of Sandimmune to prevent side effects.
• Cancer Drugs: Taking Sandimmune with cancer drugs like daunorubicin, doxorubicin, etoposide, mitoxantrone, and melphalan may increase the risk of side effects or kidney damage.
• Fluid-Reducing Drugs: Drugs like triamterene and amiloride can raise potassium levels, causing heart rate changes, fatigue, and muscle weakness.

[Note: This isn’t a complete list, and there could be other drugs that interact with Sandimmune. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

What Are the Sandimmune Alternatives?

• Cequa (cyclosporine ophthalmic solution)
• Xiidra (lifitegrast)
• TheraTears (artificial tears)
• Refresh (artificial tears)
• Systane (artificial tears)
• GenTeal (artificial tears)
• Optive (artificial tears)
• Blink (artificial tears)
• Eysuvis (loteprednol etabonate)
• Lacrisert (hydroxypropyl cellulose ophthalmic insert)
• Restasis MultiDose (cyclosporine ophthalmic emulsion in a multi-dose bottle)
• FreshKote (polyvinyl alcohol)
• Klarity-C (cyclosporine)
• Punctal plugs (medical devices, not a medication)
• AzaSite (azithromycin)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

Sandimmune Cost & Coupons

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Frequently Asked Questions

How to tell if Sandimmune is working?

To evaluate whether Sandimmune is effective in your treatment, look for the following signs:

• Organ Transplant Patients: There is no rejection of the transplanted organ or tissue. This means your body is accepting the transplant without any signs of an immune system attack.
• Rheumatoid Arthritis (RA) Patients: You should experience a reduction in symptoms of RA, such as less joint pain and swelling. An improvement in your overall mobility and a decrease in morning stiffness can also be indicators that Sandimmune is working.
• Psoriasis Patients: There should be a noticeable reduction in the number and severity of psoriasis plaques. Clearer skin and less scaling or flaking are good signs that the medication is successfully managing your condition.

What is the difference between Sandimmune and cyclosporine modified?

Sandimmune and Cyclosporine Modified (Neoral) both contain the active ingredient cyclosporine, yet they differ significantly in how they are absorbed by the body:

• Sandimmune (Cyclosporine): This is the original formulation of cyclosporine. The absorption of Sandimmune into the body can vary, which means its effectiveness may fluctuate depending on individual differences in how the drug is metabolized.
• Cyclosporine Modified (Neoral): Neoral is a newer version of cyclosporine that offers improved and more consistent absorption compared to Sandimmune. 

Can I take vitamin D with Sandimmune?

Currently, there are no known interactions between cyclosporine (the active ingredient in Sandimmune) and Vitamin D3. However, this absence of known interactions does not guarantee that none exist.

Which is safer methotrexate or Sandimmune?

Methotrexate and Sandimmune are both generally well-tolerated medications used to treat severe psoriasis, with most side effects being minor, temporary, and manageable. Methotrexate is often preferred for its rapid action and cost-effectiveness in clearing psoriasis. However, cyclosporine, the active ingredient in Sandimmune, also provides a safe and effective alternative, particularly in cases where methotrexate may not be suitable.

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