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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. CYCLOSPORINE MICROEMULSION CAPSULE - ORAL (sye-klo-SPORE-een MY-crow-ee-MULL-shun) COMMON BRAND NAME(S): Gengraf, Neoral
WARNING: Cyclosporine is a drug that reduces the body's ability to fight illness/disease (an immunosuppressant), leaving patients vulnerable to infection or other problems (including cancers such as lymphoma). Using other drugs that treat organ transplant rejection along with this drug may increase these tendencies. Cyclosporine can also cause high blood pressure and kidney problems. The risk of both problems increases with higher doses and longer treatment with this drug. Psoriasis patients who have had certain previous treatments (e.g., coal tar, methotrexate, PUVA, UVB, or other radiation therapy) are at increased risk to develop skin cancer. Therefore, cyclosporine must be given only under close medical supervision. Because different brands deliver different amounts of medication, do not switch brands of cyclosporine without your doctor's permission and directions. Laboratory tests (e.g., kidney function tests, blood tests) may be performed to monitor your progress.
USES: This medication is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine is also used to treat severe rheumatoid arthritis and a certain skin condition (severe psoriasis). Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by slowing down your body's defense system (immune system) to prevent your body from rejecting a transplanted organ, further damaging your joints (in rheumatoid arthritis patients), or further damaging your skin (in psoriasis patients). For the treatment of psoriasis or arthritis, it is generally used to treat people who cannot take other medications or have not found relief from other treatments.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to prevent rejection in other types of organ transplants (e.g., cornea, pancreas) or bone marrow transplant. It may also be used to treat other conditions that may be helped by affecting the immune system (e.g., Crohn's disease).
HOW TO USE: Take this medication by mouth, usually twice daily at the same times each day, or take as directed by your doctor. You may take this medication with or without food, but you should choose one or the other and take every dose that way. If you take this medication with food, eat the same amount and type of food each time you take it. Swallow this medication whole. Do not crush or chew the capsules. Dosage is based on your medical condition, cyclosporine blood level, kidney function, and response to therapy. Follow the dosing schedule for this medication carefully. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit products can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. If you are taking this drug to treat arthritis, it may take 4-8 weeks to notice improvement, and up to 4 months for the full benefit. If you are taking this drug to treat psoriasis, it may take 2-4 weeks to notice improvement, and up to 4 months for the full benefit. Your dose will slowly be increased during your therapy with this drug. Inform your doctor if your condition does not improve after 6 weeks of taking the highest recommended dose. If you are taking this medication to treat psoriasis, do not take it continuously for longer than one year unless directed to do so by your doctor.
SIDE EFFECTS: See also the Warning section. Headache, nausea, vomiting, diarrhea, stomach upset, acne, cramps, increased hair growth on the face/body, shaking fingers/hands (tremor), swollen/red/painful gums, dizziness, flushing, and high blood pressure may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Your risk of infection may be higher while you are taking this medication. Tell your doctor immediately if any of these symptoms of infection occur: fever, sore throat, flu-like symptoms, painful urination. Tell your doctor immediately if any of these unlikely but serious side effects occur: severe muscle spasms, fast/irregular heartbeat, muscle weakness, confusion, change in the amount/color of urine, unusual weight gain/loss, tingling of the hands/feet, hearing problems, easy bruising/bleeding, unusual tiredness. Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the skin/eyes, vomit that looks like coffee grounds, change in the appearance or size of skin moles/lesions, changes in skin color, loss of consciousness, mental/mood changes, vision changes, swollen glands, unusual lumps, night sweats. Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking cyclosporine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of chickenpox/shingles, uncontrolled high blood pressure, cancer, skin lesions of unknown cause, current use of radiation therapy (including phototherapy with PUVA or UVB), kidney problems (for arthritis or psoriasis patients only). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, any recent/current infections, seizures, untreated mineral imbalance (e.g., low magnesium or high potassium), blood disorders, diabetes, a certain gut problem (malabsorption), high blood fats (cholesterol or triglycerides). This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. This drug may reduce the magnesium levels in your blood. Ask your doctor about adding magnesium to your diet. Your doctor may prescribe a magnesium supplement. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or nasal flu vaccine. Avoid contact with people who have the flu or other contagious illness. This drug may increase your risk for developing skin cancer. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors. This medication may cause swelling and growth of the gums (gingival hyperplasia). Brush your teeth and floss daily to minimize this problem. See your dentist regularly. The elderly may be at greater risk for the effects on blood pressure and kidneys while using this drug. This medication should be used only when clearly needed during pregnancy. Cyclosporine used during pregnancy has resulted in newborns with problems such as low birth weight and being born too early (premature). Other more serious problems have also been reported, including death of the unborn baby. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also the How to Use section. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. This drug should not be used with the following medications because very serious interactions may occur: bosentan, coal tar, live vaccines, tacrolimus. If you are currently using any of these medications, tell your doctor or pharmacist before starting cyclosporine. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: birth control pills, caspofungin, ezetimibe, drugs that worsen kidney problems (e.g., acyclovir, aminoglycoside antibiotics including tobramycin; amphotericin B; colchicine; fibrates including fenofibrate; melphalan; NSAIDs including diclofenac and sulindac; ranitidine; sulfa drugs including sulfamethoxazole; vancomycin), drugs affecting liver enzymes that remove cyclosporine from your system (such as allopurinol; amiodarone; azole antifungals including fluconazole and ketoconazole; barbiturates including phenobarbital; bromocriptine; calcium channel blockers including diltiazem, nicardipine, and verapamil; cimetidine; HIV protease inhibitors including indinavir; imatinib; macrolide antibiotics including erythromycin; certain man-made male hormones such as danazol and methyltestosterone; methylprednisolone; metoclopramide; metronidazole; nafcillin; nefazodone; octreotide; quinupristin/dalfopristin; rifamycins including rifampin; certain anti-seizure drugs including carbamazepine and phenytoin; St. Johns wort; ticlopidine), nifedipine, orlistat, sulfinpyrazone, temsirolimus, terbinafine, drugs that may increase potassium levels (e.g., ACE inhibitors including lisinopril, ARBs including losartan, potassium supplements, "water pill" including amiloride, spironolactone). This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include aliskiren, digoxin, dronedarone, etoposide, repaglinide, tolterodine, certain statins (atorvastatin, lovastatin, rosuvastatin, simvastatin), other immunosuppressants (such as azathioprine, methotrexate, sirolimus), among others. Do not use potassium-containing salt substitutes while taking this medication. Consult your doctor or pharmacist for more information. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
NOTES: Do not share this medication with others. Keep all laboratory and medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function, blood pressure, blood mineral levels, uric acid, cyclosporine blood levels) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details. Have your blood pressure checked regularly while taking this medication. Discuss with your doctor how to monitor your own blood pressure. Inform your doctor of your blood pressure readings. If you have had an organ transplant, it is recommended that you attend a transplant education class or support group. Learn the symptoms of organ rejection such as a feeling of being ill, fever, pain around the transplanted organ, and signs of a failing transplanted organ (a decrease in the amount of urine with kidney transplant, yellowing of the skin/eyes with liver transplant, shortness of breath/inability to exercise with heart transplant). Seek immediate medical attention if these symptoms of rejection occur.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store in the original foil container at room temperature away from heat and moisture. Different storage temperatures are needed for drugs from different manufacturers, so consult your pharmacist for more information. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada). Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.
Prescription Return Policy
We are prevented by law from accepting returns for any prescription medication. If you need to dispose of any medication, please follow the steps below...
FDA Guidelines on Proper Methods of Disposing of Unused Medicine
For guidelines on proper methods of disposing of unused medicines, consult the following FDA link: www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm
As a general rule of thumb, do not flush prescription drugs down the toilet or drain unless the label or accompanying patient information specifically instructs you to do so. For information on drugs that should be flushed visit the FDA’s website.
To dispose of prescription drugs not labeled to be flushed, you may be able to take advantage of community drug take-back programs or other programs, such as household hazardous waste collection events, that collect drugs at a central location for proper disposal. Call your city or county government’s household trash and recycling service and ask if a drug take-back program is available in your community.
If a drug take-back or collection program is not available:
1. Take your prescription drugs out of their original containers.
2. Mix drugs with an undesirable substance, such as cat litter or used coffee grounds.
3. Put this mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag.
4. Conceal or remove any personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off.
5. Place the sealed container with the mixture, and the empty drug containers, in the trash.
Shipping Policy
Although we strive to fill your medication as quickly as possible, we are not an urgent facility. Please obtain a local fill of your medication if you have an emergency or urgent needs to ensure no disruption with your medical therapy.
All orders ship from Titusville, FL. We offer 100% FREE shipping on all orders. We ship orders Monday through Friday. We only ship to valid street addresses within the state of Florida. No Post Office boxes.
For all orders, you can expect the following shipping times: 1-2 business days.
Please note that prescription items cannot be shipped until a valid, verified prescription is on file. In addition to the shipping times stated above, please add up to 1-2 business days of processing time to all orders.
Offer to Counsel
If you have any questions regarding this prescription or any other medication, please feel free to contact us at info@atyourdoorpharmacy.com or during store counseling hours (Mon-Fri, 9am-6pm, Eastern) at (407) 476-1721.
Health Insurance Portability & Accountability Act
At Your Door is committed to protecting your privacy. As a healthcare provider, we know that your trust in us is of central importance. This policy discloses our information use and policies and procedures in detail. Please read it to learn more about the ways we protect the information we collect and to find out how you can limit the information about you that is shared. If At Your Door should change its information practices, we will provide you notice of any material changes.
Strict Security Measures
At Your Door takes the security of information very seriously and has established security standards and procedures to prevent unauthorized access to patient information. We maintain physical, electronic, and procedural safeguards to comply with federal standards to guard patient information.
The following are ways AtYourDoorPharmacy.com will use and disclosure your Personal Health Information (PHI). Every allowable use or disclosure may not be listed:
For Treatment AtYourDoorPharmacy.com will use and disclose PHI to coordinate and manage your healthcare in order to dispense your prescription medication.
For Payment AtYourDoorPharmacy.com will use and disclose PHI to receive payment for our services. We may disclose your PHI to other HIPAA covered entities or business associates who may need it for their processing of your healthcare payments.
For Healthcare Operations AtYourDoorPharmacy.com will use and disclose PHI for administrative purposes to evaluate and improve the quality of care we provide you.
We may also use or disclose PHI for the following purposes
Business associates AtYourDoorPharmacy.com may provide some services through contracts with HIPAA compliant business associates. The business associates must enter into a confidentiality agreement to protect your PHI from unauthorized use and disclosure.
Communication with individuals involved in your care If you do not object, AtYourDoorPharmacy.com may disclose PHI to a friend or family member who is involved in your care.
Parents or legal guardians If you are a minor, we may release your PHI to your parents or legal guardians when we are permitted or required to do so under federal and applicable state law.
Health related communications AtYourDoorPharmacy.com may contact you to provide refill reminders or other health-related services that may be of interest to you as permitted by law.
As required by law We may disclose PHI when required to do so by federal, state or local law.
Law enforcement We may disclose PHI for law enforcement purposes, in response to a subpoena or other legal process.
Public Health As required by law, we may disclose PHI about you to public health authorities to prevent or control a serious threat to the health and safety of another person. We may also disclose PHI for the purpose of reporting adverse events and product recalls
Health Oversight Activities We may disclose PHI to an oversight agency for activities authorized by law. These activities would include pharmacy investigations, audits, credentialing and inspections required for our licensure. These are governmental agencies who monitor the health care system who are subject to government regulation and civil right laws.
Judicial and administrative proceedings We may disclose your PHI in response to a subpoena, court or administrative order, or other lawful process, but only if efforts were made to notify you about the request or to obtain an order protecting the requested PHI as required by law.
Coroners, medical examiners, and funeral directors We may disclose PHI to a coroner or medical examiner. This may be necessary to identify a deceased person or determine the cause of death. We may also disclose PHI to funeral directors as necessary with applicable laws so they may carry out their duties.
Organ, eye and tissue donation We may disclose PHI, consistent with applicable law to organizations who engage in organ procurement or transplant to facilitate the donation.
Research Under certain circumstances, we may disclose PHI for research purposes. Before disclosing PHI we would either remove information that personally identifies you or obtain your written authorization.
Military and Veterans Under certain circumstances, we may disclose to military authorities PHI or armed forces personnel.
National Security We may disclose PHI to authorized federal officials for intelligence, counterintelligence, and other national security activities authorized by law.
Correctional Institution We may disclose PHI of an inmate to the institution when necessary for your health or the health and safety of others.
Workers’ compensation We may disclose your PHI to comply with Workers’ Compensation Laws or other similar programs.
Individual Rights
In most cases, you have the right to look at or get a copy of health information about you that we use to make decisions about your care. You also have the right to receive a list of instances where we have disclosed health information about you for reasons other than treatment, payment, or related administrative purposes. If you believe that information in your record is incorrect or if important information is missing, you have the right to request that we correct or add the missing information. We will take precautions to prevent inappropriate or non-essential use or distribution of patient information when transmitted via the Internet and while the pharmacy possesses such information. You may request in writing that we not use or disclose your information for treatment payment and administrative purposes except when specifically authorized by you, when required by law, or in emergencies. We will consider your request but are not legally required to accept it.
Other Uses and Disclosures of your PHI
We are required by law to protect the privacy of your information, provide this notice of our information practices, and follow the information practices described in this notice. AtYourDoorPharmacy.com will request written authorization from you before using or disclosing your PHI for purposes not included in this document or as otherwise permitted or required by law. If you provide authorization and want to revoke this authorization at any time, or have any questions or complaints, this can be done in writing at any time by sending a written request to:
Atyourdoorpharmacy.com
Attn: Privacy Officer
100 E. Pine St.Suite 110
Orlando, FL
You may also call if you have any questions or complaints, please contact AtYourDoorPharmacy.com at (407) 476-1727
This revocation will not affect any use or disclosure of your PHI allowed by your authorization while it was in effect.