Tecovirimat

What is Tecovirimat?

Tecovirimat (TPOXX) is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein used to treat smallpox disease.

What are the uses of this medicine?

• This medicine is used to treat smallpox disease caused by a type of virus called variola virus in adults and children who weigh at least 13 kg.

How does this medicine work?

• Tecovirimat targets and inhibits the activity of the orthopoxvirus VP37 protein (encoded by and highly conserved in all members of the orthopoxvirus genus) and blocks its interaction with cellular Rab9 GTPase and TIP47, which prevents the formation of egress-competent enveloped virions necessary for cell-to-cell and long-range dissemination of virus.

Who Should Not Use this medicine ?

Limitations of Use:

• TPOXX may not work well in people who have a weakened immune system.
• 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 of TPOXX in children 17 years of age and younger.

What drug interactions can this medicine cause?

• Monitor blood glucose and monitor for hypoglycemic symptoms in patients when TPOXX is co-administered with repaglinide.
• Monitor for effectiveness of midazolam when co-administered with TPOXX.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Recommended Dosage

Dosage for Adults and Pediatric Patients Weighing at Least 40 kg

• 600 mg twice daily for 14 days

Dosage for Pediatric Patients

• 13 kg to less than 25 kg: 200 mg of TPOXX twice daily for 14 days
• 25 kg to less than 40 kg: 400 mg of TPOXX twice daily for 14 days
• 40 kg or more: 600 mg of TPOXX twice daily for 14 days

Administration

• Take TPOXX exactly as your healthcare provider tells you.
• For adults and children who weigh at least 40 kg, take 3 capsules of TPOXX twice a day by mouth for 14 days.
• TPOXX should be taken within 30 minutes after eating a full, fatty meal. Talk to your healthcare provider about examples of foods that you can eat that contain about 25 grams of fat. Always take TPOXX with food.
• Stay under the care of your healthcare provider during treatment with TPOXX.
• Do not change your dose or stop taking TPOXX without talking to your healthcare provider.
• It is important to take TPOXX for the full 14 day course of treatment.
• Do not miss or skip a dose of TPOXX.
• If you take too much TPOXX, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsule: 200 mg.

This medicine is available in fallowing brand namesː

• TPOXX

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea
• stomach pain
• vomiting

TPOXX may cause serious side effects, including: Low blood sugar (hypoglycemia),symptoms may include:

• headache
• drowsiness
• hunger
• feeling jittery or shaky
• dizziness
• confusion
• sweating
• weakness
• fast heartbeat
• irritability

What special precautions should I follow?

• Co-administration with repaglinide may cause hypoglycemia. Monitor blood glucose and monitor for hypoglycemic symptoms during co-administration.

What to do in case of emergency/overdose?

There is no clinical experience with overdosage of TPOXX.

Management for overdosage:

• In case of overdosage, monitor patients for any signs or symptoms of adverse effects.
• Hemodialysis will not significantly remove TPOXX in overdosed patients.

Can this medicine be used in pregnancy?

• No adequate and well-controlled studies in pregnant women were conducted; therefore there are no human data to establish the presence or absence of TPOXX associated risk.

Can this medicine be used in children?

• As in adults, the effectiveness of TPOXX in pediatric patients is based solely on efficacy studies in animal models of orthopoxvirus disease.
• The dosage for pediatric patients is based on weight.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tecovirimat
• Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell is made of gelatin, FD&C blue #1, FD&C red #3, FD&C yellow #6, and titanium dioxide.

Who manufactures and distributes this medicine?

Manufactured by: Catalent Pharma Solutions 1100 Enterprise Drive Winchester, KY 40391

Distributed By: SIGA Technologies, Inc. 4575 SW Research Way Corvallis, OR 97333

What should I know about storage and disposal of this medication?

• Store TPOXX at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep TPOXX in its original container.
• Keep TPOXX and all other medicines out of the reach of children.

• Dailymed label info on Tecovirimat
• FDA Tecovirimat