Cyclodextrin

TPOXX is a prescription medicine used to treat smallpox disease caused by a type of virus called variola virus in adults and children who weigh at least 7 pounds (3 kg). The effectiveness of TPOXX has been studied only in animals with orthopoxvirus diseases. There have been no human studies in people who have smallpox disease. The safety of TPOXX was studied in adults. There have been no studies in children 17 years of age and younger. TPOXX may not work well in people who have a weakened immune system (immunocompromised). TPOXX works as an antiviral by inhibiting the orthopoxvirus VP37 envelope wrapping protein.

TPOXX is a prescription medicine used to treat smallpox disease caused by a type of virus called variola virus in adults and children who weigh at least 7 pounds (3 kg). The effectiveness of TPOXX has been studied only in animals with orthopoxvirus diseases. There have been no human studies in people who have smallpox disease. The safety of TPOXX was studied in adults. There have been no studies in children 17 years of age and younger. TPOXX may not work well in people who have a weakened immune system (immunocompromised). TPOXX works as an antiviral by inhibiting the orthopoxvirus VP37 envelope wrapping protein.

Before taking or receiving TPOXX, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child: have diabetes. have kidney problems. are pregnant or plan to become pregnant. It is not known if this medicine can harm the unborn baby. Tell your healthcare provider if you or your child become pregnant during treatment. are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You should not breastfeed during treatment. You should not breastfeed if you have smallpox because of the risk of passing variola virus to the breastfed infant. Talk to your healthcare provider about the best way to feed your baby during treatment.

TPOXX may cause serious side effects, including: Low blood sugar (hypoglycemia). Low blood sugar can happen when TPOXX is taken or received with repaglinide, a medicine used to treat type 2 diabetes. Tell your healthcare provider if you get any of the following symptoms of low blood sugar: headache dizziness weakness drowsiness confusion fast heartbeat hunger sweating irritability feeling jittery or shaky The most common side effects of TPOXX capsules include: headache stomach pain nausea vomiting The most common side effects of TPOXX injection include: reactions at the site of your IV infusion These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The drug should be used with caution during pregnancy, neonates and the patient of asthma.

Drug should not be given to Pregnant Mothers, and Cardiac / Hypertensive Patients.If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.

0.153 mg/kg.min (0.15 (0.153)) As recommended. IV Inf — For 180 minutes, every 2-3 weeks Scraped Dose — Take the capsules exactly as your healthcare provider tells you. Do not change the dose or stop treatment without talking to your healthcare provider. For adults and children who weigh at least 40 kg and less than 120 kg, take 3 capsules of TPOXX 2 times a day (every 12 hours) by mouth for 14 days. For adults and children who weigh at least 120 kg, take 3 capsules of TPOXX 3 times a day (every 8 hours) by mouth for 14 days. TPOXX should be taken within 30 minutes after eating a full meal of moderate or high fat (approximately 600 calories and 25 grams of fat). Swallow capsules whole with 6 to 8 ounces of water. Talk to your healthcare provider about examples of foods that you can eat that contain about 25 grams of fat. Always take the capsules with food. See the Instructions for Use that comes with your prescription for instructions on how to prepare and take a dose if: your child weighs less than 88 pounds (40 kg), or you or your child have trouble swallowing the capsules. It is important to take TPOXX for the full 14 day course of treatment. Do not miss or skip a dose. If you miss an oral dose, you should take the dose as soon as possible and anytime up to 8 hours before the next scheduled dose. If less than 8 hours remain before the next scheduled dose, do not take the missed dose, and take your next dose as scheduled. If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away. TPOXX Injection for Intravenous Infusion (IV): TPOXX injection is given to you or your child by intravenous (IV) infusion into a vein slowly over 6 hours using an infusion pump by a health care provider.

No child dosage information is recorded for this medicine yet.

0.01 to 0.4 ug/kg/min (0.2 (0.205)) As recommended. Infusion — Maintenance, As required 0.05 to 0.1 ug/kg/min (0.075 (0.075)) As recommended. Infusion — Initial

Tell your healthcare provider about all of the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using TPOXX with certain other medicines may affect each other causing possible serious side effects. You can ask your healthcare provider or pharmacist for a list of medications that interact with TPOXX. Especially tell your healthcare provider if you take a medicine used to treat type 2 diabetes called repaglinide. Know the medicines you or your child take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TPOXX with other medicines.

Store in a well closed container.