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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. VALGANCICLOVIR- ORAL (val-gan-SIGH-klow-veer) COMMON BRAND NAME(S): Valcyte
WARNING: Valganciclovir turns into the drug ganciclovir inside your body. Ganciclovir can decrease bone marrow function. This serious, possibly life-threatening side effect may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, and cause bleeding problems. Your doctor will check the results of your blood tests and adjust your treatment to reduce your risk for these side effects. Seek immediate medical attention if you develop signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), signs of infection (such as fever, chills, cough, persistent sore throat), and signs of bleeding (such as easy bruising/bleeding, nose bleeds, bleeding gums, bloody/black/tarry stools, vomit that looks like coffee grounds). Based on animal studies, ganciclovir may reduce fertility in men and women. It may also harm an unborn baby. Talk to your doctor for more details. Ganciclovir has caused tumors in laboratory animals. Although there is no information in humans, valganciclovir should be considered cancer-causing (carcinogenic). See also How to Use and Precautions sections.
USES: Valganciclovir is an anti-viral drug. It is changed in the body to the active form of the drug called ganciclovir. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Valganciclovir works by slowing the growth of the CMV virus. It helps prevent the spread of infection to other areas of the body. Valganciclovir is also used to treat CMV retinitis in people with advanced HIV disease (AIDS). This medication helps control CMV retinitis and decrease the risk of blindness. Valganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. Therefore, it is important to have your eyes checked regularly by your doctor.
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 reduce the risk of CMV disease in people receiving cancer chemotherapy treatment.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking valganciclovir and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with food, usually 1 to 2 times a day or as directed by your doctor. Swallow the tablets whole. Do not crush or break the tablets. If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using the special measuring device provided. Do not use a household spoon because you may not get the correct dose. Wash your hands well after handling this drug. Avoid contact with broken/crushed tablets and the liquid form of this medication on your skin, in your mucous membranes and eyes, and avoid breathing in the dust from the tablets. If contact should occur, wash the area thoroughly with soap and water. If this medication gets in your eyes, rinse them thoroughly with plain water. The dosage and length of treatment is based on your medical condition (especially kidney function). In children, the dosage is also based on their body size. The doctor should keep track of your child's height and weight to make sure that the dose is right for them. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day. Continue taking this medication exactly as prescribed by your doctor. Do not change your dose or stop taking it even for a short time unless directed to do so by your doctor. Changing or skipping your dose without approval from your doctor may increase the risk of side effects or make the infection worse. Do not take ganciclovir instead of valganciclovir on your own without consulting your doctor or pharmacist. The effects and the dosages of ganciclovir and valganciclovir are not equal. Keep all medical and laboratory appointments. Tell your doctor if your condition worsens (such as worsening vision).
SIDE EFFECTS: See also Warning section. Diarrhea, upset stomach, dizziness, drowsiness, unsteadiness, or shaking (tremors) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), signs of kidney problems (such as change in the amount of urine), seizures. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. 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 valganciclovir, tell your doctor or pharmacist if you are allergic to it; or to ganciclovir or acyclovir; 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems (such as kidney dialysis), a low number of blood cells (red or white blood cells, platelets), radiation treatment. This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Older adults may be at greater risk for kidney problems while using this drug. Women who are pregnant or who may become pregnant should not handle this medication. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. Women of child-bearing age should have a pregnancy test before starting this medication. To prevent pregnancy, men with female partners should always use effective barrier protection (such as latex or polyurethane condoms) during all sexual activity during treatment and for at least 90 days after stopping the medication. Women of child-bearing age who are taking valganciclovir should use reliable forms of birth control (such as birth control pills and condoms) during treatment and for at least 30 days after stopping the medication. Consult your doctor for more details. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. If you have HIV, do not breast-feed because breast milk can transmit HIV.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: didanosine, imipenem/cilastatin. You may be taking other drugs that decrease bone marrow function and lower your number of blood cells (such as cancer chemotherapy, trimethoprim/sulfamethoxazole, zidovudine) or other drugs that may cause kidney problems (such as cyclosporine). Your doctor or pharmacist will monitor you closely and adjust your medications to decrease your risk of serious side effects. Valganciclovir is very similar to ganciclovir. Do not use medications containing ganciclovir while using valganciclovir.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as complete blood count, kidney function, eye exams) should be performed often to monitor your progress or check for side effects. Consult your doctor for more details.
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. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store the tablets at room temperature away from light and moisture. Do not store in the bathroom. Store the liquid form of this medication in the refrigerator. Do not freeze. The medication expires 49 days after it was prepared by the pharmacy. Keep all medications 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. Information last revised June 2018. Copyright(c) 2018 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.