Tecovirimat Siga

Package leaflet: Information for the user

Tecovirimat SIGA 200 mg hard capsules

tecovirimat
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. (See section 4).

Contents of this leaflet

1. What Tecovirimat SIGA is and what it is used for
2. What you need to know before taking Tecovirimat SIGA
3. How to take Tecovirimat SIGA
4. Possible side effects
5. How to store Tecovirimat SIGA
6. Contents of the pack and other information

1. What Tecovirimat SIGA is and what it is used for

Tecovirimat SIGA contains the active substance tecovirimat.
Tecovirimat SIGA is used to treat viral infections such as smallpox, mpox, and cowpox in adults and
children weighing at least 13 kg.
Tecovirimat SIGA is also used to treat complications arising from smallpox vaccines.
Tecovirimat SIGA works by blocking the spread of the virus. This allows the body to develop protection against the virus while you recover.

2. What you need to know before taking Tecovirimat SIGA

Do not take Tecovirimat SIGA

• if you are allergic to Tecovirimat SIGA or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tecovirimat SIGA

• if your immune system is not working properly (immunodeficiency), or if you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or cancer medicines).
• if your liver or kidney function is reduced.

Children weighing less than 13 kg
This medicine must not be given to children weighing less than 13 kg.
Other medicines and Tecovirimat SIGA
Tell your doctor if you are taking, have recently taken, or might take any other
medicine. Inform your doctor if you are taking any of the following medicines:

• repaglinide (a medicine used to treat blood sugar in diabetes)
• omeprazole, lansoprazole or rabeprazole (used to treat ulcers or heartburn)
• midazolam (a medicine used to sedate people before a surgical procedure)
• bupropion (a medicine used to treat depression)
• atorvastatina (a medicine used to treat high cholesterol)
• flurbiprofen (a medicine used for pain)
• methadone (a medicine used for pain or for narcotic withdrawal symptoms)
• darunavir, maraviroc or rilpivirine (used to treat HIV infection)
• sildenafil, tadalafil or vardenafil (used to treat erectile dysfunction)
• voriconazole (a medicine used to treat fungal infections)
• tacrolimus (a medicine used to suppress the immune system).

Taking Tecovirimat SIGA together with any of these medicines may prevent them from working properly or may worsen any side effects. Your doctor may need to prescribe you a different medicine or adjust the dose of the medicine you are taking. The above list is not exhaustive regarding medicines your doctor may need to adjust.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Tecovirimat SIGA is not recommended during pregnancy.
It is not known whether Tecovirimat SIGA is excreted in breast milk. Breastfeeding is not recommended during treatment with this medicine. Inform your doctor if you are breastfeeding or intend to breastfeed before taking this medicine.
Driving and using machines
Do not drive or operate machinery if you feel dizzy.
Tecovirimat SIGA contains lactose and sunset yellow (E110)

• Tecovirimat SIGA contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
• This medicine also contains sunset yellow (E110), a colouring agent. It may cause allergic reactions.

3. How to take Tecovirimat SIGA

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing at least 13 kg
The recommended doses are shown in the table below.

Method of administration
Take Tecovirimat SIGA within 30 minutes after consuming a full meal containing at least 600 calories.
The meal must contain at least 25 grams of fat. This can be achieved with many common foods (e.g., 2 generous handfuls of walnuts, 2 tablespoons of oil, or 1.5 tablespoons of butter).
This is very important to ensure that the body absorbs a sufficient amount of the medicine.
Swallow the capsules whole with 150–200 mL of water.

Adults and children with difficulty swallowing capsules
For patients unable to swallow the capsules, the doctor may recommend opening the hard capsule and mixing the contents with 30 mL of liquid (e.g., milk, chocolate milk) or soft food (e.g., applesauce, yogurt).

Wash and dry hands before and after preparation. Carefully open the capsule to avoid spillage or dispersion of the contents into the air. Hold the capsule with the cap facing upwards and gently pull the cap away from the body of the capsule. Use a small container for mixing.

Mix the entire contents of the capsule with 30 mL of liquid (e.g., milk) or soft food (e.g., yogurt). The mixture must be taken within 30 minutes of mixing and within 30 minutes after a meal.

Instructions for preparation and the recommended dosage for adult and pediatric patients are provided in the table below.

If you take more Tecovirimat SIGA than you should
Inform your doctor if you have taken an excessive number of Tecovirimat SIGA capsules so that you can be monitored for signs or symptoms of adverse effects.

If you forget to take Tecovirimat SIGA
If you miss a dose, skip it and continue with your next scheduled dose. Do not take a double dose to make up for the missed dose.

If you stop taking Tecovirimat SIGA, your symptoms may return or worsen
Do not stop treatment with Tecovirimat SIGA before completing the full course, or without first consulting your doctor or pharmacist.

If you vomit after taking Tecovirimat SIGA
If you vomit within 30 minutes of taking Tecovirimat SIGA, you may take another dose immediately. If you vomit more than 30 minutes after taking Tecovirimat SIGA, do not take another dose and continue with your next scheduled dose.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.

Very common side effects (may affect more than 1 in 10 people)

• Headache

Common side effects (may affect up to 1 in 10 people)

• Dizziness
• Nausea or vomiting
• Diarrhoea
• Abdominal pain

Uncommon side effects (may affect up to 1 in 100 people)

• Reduced appetite
• Increased liver enzymes
• Depression or anxiety
• Irritability
• Depression
• Panic attacks
• Migraine
• Feeling of tiredness, sleepiness, or inability to fall asleep
• Difficulty concentrating or reduced attention
• Taste disturbances
• Tingling or numbness of hands, feet, or mouth
• Mouth pain
• Constipation
• Flatulence
• Indigestion or stomach discomfort
• Abdominal discomfort or bloating
• Dry mouth
• Dry or chapped lips
• Mouth ulcers
• Belching
• Heartburn
• Itching or skin rash (urticaria)
• Joint pain and stiffness
• Fever
• Chills
• General feeling of being unwell
• Pain
• Feeling of thirst
• If you undergo a brain electrical activity scan called electroencephalogram (EEG), this test may show abnormal readings of brain electrical activity.
• If you have a blood test, this test may show a lower than normal number of red blood cells, white blood cells, or platelets.
• Increased heart rate (tachycardia) or irregular heartbeat

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tecovirimat SIGA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Store at a temperature below 25°C.
Do not use this medicine if you notice that the capsule is cracked or damaged in any way.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Tecovirimat SIGA contains

• The active substance is tecovirimat monohydrate, equivalent to 200 mg of tecovirimat.
• The other components are:
  Capsule core: anhydrous colloidal silica, sodium croscarmellose (E468), hypromellose (E464), monohydrate lactose, magnesium stearate, microcrystalline cellulose (E460), and sodium lauryl sulfate (E487).
  Capsule shell: gelatin, Brilliant Blue FCF (E133), erythrosine (E127), Sunset Yellow (E110), and titanium dioxide (E171).
  Printing ink: shellac (E904), titanium dioxide (E171), isopropyl alcohol, ammonium hydroxide (E527), butyl alcohol, propylene glycol, and simethicone.

Description of the appearance of Tecovirimat SIGA and pack contents

• Tecovirimat SIGA capsules are orange and black, each printed with ‘SIGA®’ and ‘ST-246’ in white ink. The capsules are 21.7 millimetres in length and have a diameter of 7.64 millimetres.
• Tecovirimat SIGA is available in a pack containing 84 capsules (2 bottles of 42 capsules each).

Marketing Authorisation Holder
SIGA Technologies Netherlands B.V.
Prinsenhil 29,
Breda 4825 AX,
The Netherlands

Manufacturer
Millmount Healthcare Limited
Block-7, City North Business Campus,
Stamullen
Co. Meath
K32 YD60
Ireland

This medicinal product has been granted a marketing authorisation under "exceptional circumstances". This means that for ethical reasons, it has not been possible to obtain complete information about this medicinal product.
The European Medicines Agency will review any new information on this medicinal product annually, and this package leaflet will be updated if necessary.

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

ANNEX IV
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION

Scientific conclusions
Taking into account the assessment of the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for tecovirimat, the scientific conclusions are as follows:
In light of available data on the risk of treatment failure from the literature and spontaneous reports, the PRAC rapporteur concluded, in agreement with the comments from another Member State, that the product information for Tecovirimat SIGA should be amended accordingly. These amendments are particularly important in view of the current monkeypox outbreak (WHO Public Health Emergency of International Concern).
Having reviewed the PRAC recommendation, the Committee for Human Medicinal Products (CHMP) agrees with the overall conclusions and the rationale provided in the recommendation.

Grounds for the variation to the terms of the marketing authorisation
Based on the scientific conclusions on tecovirimat, the CHMP considers that the benefit-risk balance of the medicinal product Tecovirimat SIGA remains unchanged, subject to the proposed amendments to the product information.
The CHMP recommends the variation to the terms of the marketing authorisation.