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Generated Narrative: Bundle TEST PURPOSES ONLY - hepcludex

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Generated Narrative: MedicinalProductDefinition mpb09f5aad6df76e91a7314393eef4e2a9

identifier: http://ema.europa.eu/identifier/EU/1/20/1446/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: HEPCLUDEX 2 mg powder for solution for injection

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

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-	Country	Jurisdiction	Language
*	EU	EU	en

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Generated Narrative: Composition composition-en-b09f5aad6df76e91a7314393eef4e2a9

identifier: http://ema.europa.eu/identifier/EU/1/20/1446/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - hepcludex

Attesters

7. Step-by-step injection guide

What is in this leaflet

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

What Hepcludex is Hepcludex contains the active substance bulevirtide, which is an antiviral medicine.

What Hepcludex is used for Hepcludex is used to treat long-term (chronic) hepatitis delta virus (HDV) infection in adults with compensated liver disease (when the liver is still working well enough). Infection with hepatitis delta virus causes inflammation of the liver.

How Hepcludex works HDV uses a particular protein in liver cells to enter the cells. Bulevirtide, the active substance in this medicine blocks the protein and so prevents the HDV from getting into liver cells. This reduces the spread of HDV in the liver and reduces inflammation.

Do not take Hepcludex:

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

If you are not sure, speak to your doctor before taking this medicine.

Warnings and precautions
Do not stop your treatment with Hepcludex unless your doctor advises you to do so. Stopping the treatment can reactivate the infection and worsen your disease.

Talk to your doctor or pharmacist before taking Hepcludex:

1. if your liver is not working well enough it is not known how well Hepcludex works in these circumstances; if your liver is not functioning well, taking Hepcludex is not recommended.

2. if you have had kidney disease or if tests have shown problems with your kidneys. Before and during treatment, your doctor may order blood tests to check how well your kidneys are working;

3. if you have HIV infection or hepatitis C - it is not known how well Hepcludex works in these circumstances; your doctor may order blood tests to check the status of your HIV or hepatitis C infection

Children and adolescents Children and adolescents under 18 years of age should not be treated with Hepcludex.

Other medicines and Hepcludex Please tell your doctor if you are taking, have recently taken, or might take any other medicines.

Some medicines can increase side effects of Hepcludex and you should not take them at the same time. This is why you should tell your doctor if you are taking any of these medicines:

1. ciclosporin, a medicine that supresses the immune system;
2. ezetimibe, used for treating high blood cholesterol;
3. irbesartan, used for treating high blood pressure and heart disease;
4. ritonavir, used to treat HIV infection;
5. sulfasalazine, (used for treating rheumatoid arthritis, ulcerative colitis, and Crohn's disease.

Some medicines can increase or decrease the effects of Hepcludex when taken together. In some cases, you may need to have certain tests or your doctor may change the dose or monitor you regularly:

1. cancer treatments (e.g. dasatinib, docetaxel, ibrutinib, paclitaxel);

2. antihistamine medicines used for allergies (e.g. ebastine, fexofenadine);

3. immune system medicines (e.g. everolimus, sirolimus, tacrolimus);

4. medicines for hepatitis C and HIV treatment (e.g. darunavir, glecaprevir, grazoprevir, indinavir, maraviroc, paritaprevir, saquinavir, simeprevir, tipranavir, voxilaprevir);

5. medicines for diabetes (e.g. glibenclamide, nateglinide, repaglinide);

6. medicines for erectile dysfunction (e.g., avanafil, sildenafil, vardenafil);

7. medicines for treating high blood pressure and heart disease (e.g. olmesartan, telmisartan, valsartan);

8. statin, medicines used for high blood cholesterol (e.g. atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin);

9. thyroid hormones used to treat thyroid problems;

10. alfentanil, an opioid medicine used to treat severe pain;

11. bosentan, used for pulmonary arterial hypertension;

12. buspirone, an anxiety medicine;

13. budesonide, used for asthma and chronic obstructive pulmonary disease;

14. conivaptan and tolvaptan, used to treat hyponatraemia (low sodium levels);

15. darifenacin, used to treat urinary incontinence;

16. dronedarone, heart medicine for cardiac arrhythmias;

17. eletriptan, used for migraine headaches;

18. eplerenone, used for high blood pressure;

19. estrone-3-sulfate a menopausal hormone medicine;

20. felodipine and nisoldipine (heart medicines);

21. lomitapide, used for high blood cholesterol;

22. lurasidone and quetiapine, antipsychotic medicines for psychiatric disorders;

23. midazolam and triazolam, medicines to treat insomnia (inability to sleep) and for anaesthesia (to avoid pain during surgery);

24. naloxegol, used to treat dependence on opioid medicines for severe pain;

25. ticagrelor, anticoagulant to prevent blood clotting.

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not use this medicine unless specifically told to by your doctor.

If you are a woman of childbearing potential, you should not take this medicine without using an effective method of contraception.

Talk to your doctor to decide whether you should breastfeed while taking Hepcludex.
It is not known whether Hepcludex can pass into breast milk. Therefore, a decision must be made whether to discontinue breast-feeding or to discontinue Hepcludex.

Driving and using machines Dizziness and tiredness are side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.

Hepcludex contains sodium This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially "sodium- free".

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Dosage The recommended dose is 2 mg once daily by subcutaneous injection (just under the skin). Your doctor will say how long you need to take the medicine for.

Your doctor and nurse will show you how to prepare and inject Hepcludex. This package leaflet contains a step-by-step injection guide to help you inject the medicine (see section 7).

If you take more Hepcludex than you should The usual dose is 2 mg (1 vial) per day. If you think you may have taken more than you should, tell your doctor immediately.

If you forget to take Hepcludex If less than 4 hours have passed since your missed dose of Hepcludex, take the missing dose as soon as possible and take your next scheduled dose at the usual time.

If more than 4 hours have passed since your missed dose of Hepcludex, do not take the missed dose. Take the next dose the following day at the usual time. Do not take a double dose to make up for the missed dose. Tell your doctor if you have missed a dose of Hepcludex.

If you stop taking Hepcludex If you do not want to take Hepcludex anymore, talk to your doctor before stopping the treatment. Stopping the treatment can reactivate the infection and worsen your disease. Tell your doctor immediately about any changes in symptoms after stopping treatment.

If you have any further questions on the use of Hepcludex, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Please tell your doctor if any of the side effects occur, or if you notice any side effects not listed in this leaflet.

The following side effect is very common (this may affect more than 1 in 10 people):

• headache
• itching
• reactions at the injection site that may include swelling, redness, irritation, bruising, itchiness, rash, hardening, infection or local pain

The following side effects are common (these may affect up to 1 in 10 people):

• dizziness
• nausea
• tiredness
• flu-like illness
• joint pain

The following side effects are uncommon (these may affect up to 1 in 100 people):

• allergic reactions, including anaphylactic reaction (sudden life-threatening allergic reaction). Symptoms of allergic reactions can include:
• shortness of breath or wheezing
• swelling of the face, lips, tongue or throat (angioedema)
• skin rashes
• changes to blood pressure or heart rate. Symptoms of anaphylactic reaction are like those of allergic reaction, but more severe and require immediate medical care.

Blood tests may also show:

• an increase in the level of bile acids in the blood (very common)
• an increase in white blood cells (eosinophils) (common).

Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help to provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C -8 C). In order to protect from light, keep the vials in the outer carton.

The reconstituted solution should be used immediately. However, if this is not possible it can be stored for up to 2 hours at a temperature of up to 25 C.

Do not throw away any medicines or used needles via wastewater or household waste. Ask your pharmacist how to safely dispose medicines and used needles.

What Hepcludex contains The active substance is bulevirtide 2 mg. Each vial contains bulevirtide acetate equivalent to 2 mg bulevirtide.

The other ingredients are: sodium carbonate anhydrous, sodium hydrogen carbonate, mannitol, hydrochloric acid, sodium hydroxide.

What Hepcludex looks like and contents of the pack Bulevirtide is a powder for solution for injection and comes as a white to off-white powder. Each carton contains 30 single doses.

Marketing Authorisation Holder Gilead Sciences Ireland UC Carrigtohill County Cork, T45 DPIreland

Manufacturer Gilead Sciences Ireland UC IDA Business and Technology Park Carrigtohill Co. Cork Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Gilead Sciences Belgium SRL-BV T l/Tel: + 32 (0) 24 01 35 Lietuva Gilead Sciences Ireland UC Tel.: + 353 (0) 1 686 1
Gilead Sciences Ireland UC .: + 353 (0) 1 686 1Luxembourg/Luxemburg Gilead Sciences Belgium SRL-BV T l/Tel: + 32 (0) 24 01 35 esk republika Gilead Sciences s.r.o. Tel: + 420 (0) 910 871 Magyarorsz g Gilead Sciences Ireland UC Tel.: + 353 (0) 1 686 1Danmark Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1Malta Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0

Nederland Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 Eesti Gilead Sciences Ireland UC Tel.: + 353 (0) 1 686 1Norge Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1
Gilead Sciences . . : + 30 (0) 210 8930 sterreich Gilead Sciences GesmbH Tel: + 43 (0) 1 260 Espa a Gilead Sciences, S.L. Tel: + 34 (0) 91 378 98 Polska Gilead Sciences Poland Sp. z o.o. Tel.: + 48 (0) 22 262 8France Gilead Sciences T l: + 33 (0) 1 46 09 41 Portugal Gilead Sciences, Lda. Tel: + 351 (0) 21 7928Hrvatska Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Rom nia Gilead Sciences (GSR) S.R.L. Tel: +40 31 631 18 Ireland Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 Slovenija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1 sland Gilead Sciences Sweden AB S mi: + 46 (0) 8 5057 1Slovensk republika Gilead Sciences Slovakia s.r.o. Tel: + 421 (0) 232 121 Italia Gilead Sciences S.r.l. Tel: + 39 02 439Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1
Gilead Sciences . . : + 30 (0) 210 8930 Sverige Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1Latvija Gilead Sciences Ireland UC Tel.: + 353 (0) 1 686 1United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC Tel: + 44 (0) 8000 113 This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.

7. Step-by-step injection guide

Before using Hepcludex, you must first read sections 1 6 of this package leaflet.

Before you begin treatment with this medicine at home, your doctor or nurse will show you how to prepare and inject Hepcludex. This guide shows how to inject the medicine yourself. Speak with your doctor or nurse if you are unclear about anything or you have questions or need more information or help. Take your time to carefully prepare and inject Hepcludex.

Injection sites Abdomen Upper thighs In order to reduce injection site reactions, you may change the site of bulevirtide injection regularly. Do not inject bulevirtide into the following areas: knee, groin, the lower or inner buttocks, directly over a blood vessel, around the navel (belly button), on scar tissue, a bruise, a mole, a surgical scar, tattoo or burn site, or where there is an injection site reaction.

1A 1B 1C 1D Storage Preparing doses Wash hands Clean vial Bulevirtide vials must be stored in the original packaging in the refrigerator (2 8 C) in order to protect bulevirtide from light.

The following instructions are for dissolving a single dose.

Wash your hands well using soap and warm water and dry them with a clean towel. Once your hands are clean, do not touch anything else other than the medicine, supplies and the area around the injection site.

Wipe the vial top with a new alcohol pad and let the top air-dry. If you touch the rubber top after cleaning it, clean it again with a new alcohol pad.

2A 2B 2C Draw up sterile water Inject sterile water into the powder Gently mix bulevirtide Pick up the syringe. Put the longer needle on.

Important! Be sure the capped needle is tight by pushing it down slightly while twisting it clockwise.

Pull off the plastic cap.

Open the sterile water for injection. Insert the needle in the vial and gently turn the water vial upside down. Make sure the tip of the needle is always below the surface of the water to help keep air bubbles from entering the syringe.

Slowly pull the plunger back to get 1.0 ml of sterile water into the syringe. Carefully remove the needle and syringe from the vial. Gently tap the bulevirtide vial to loosen the powder. Insert the needle with sterile water into the bulevirtide vial at an angle. Inject the sterile water slowly, so it can drip down the side of the vial into the bulevirtide powder.

Gently tap the bulevirtide vial with your fingertip for 10 sec to start dissolving the powder. Then gently roll the bulevirtide vial between your hands to ensure thorough mixing. Make sure no bulevirtide powder is stuck to the vial wall. Important! Do not shake the bulevirtide vial. Shaking will make the medicine foam and it will take much longer to dissolve.

2D 2E

2F Inspect bulevirtide Bulevirtide ready for injection Clean vial Once the powder starts to dissolve, just set it aside and it completely will dissolve. After tapping, it could take up to 3 min to dissolve.

When mixed completely, the bulevirtide solution should be clear. Important! Completely dissolved bulevirtide should be clear and without foam. If the bulevirtide solution appears foamy or yellowish, allow more time for it to dissolve.

If you see bubbles, gently tap the vial until they disappear. If you see any particles in the bulevirtide solution once it is (completely) dissolved, do not use that vial. Contact your doctor or pharmacist that provided it.

Reconstituted bulevirtide must be used immediately.

Clean the bulevirtide vial top again, using a new alcohol pad.

Allow it to air dry.

3A 3B 3C 3D Change and Insert needle into vial
Draw up bulevirtide Finishing preparation discard the needle Pick up the syringe.

Insert the needle into the vial of liquid bulevirtide.

Gently turn the vial upside down. Make sure the tip of
the needle is always below the surface of the bulevirtide solution to help keep air bubbles from entering the syringe. Slowly pull the plunger to get
1.0 ml of bulevirtide.

Gently tap or flick the syringe and push/pull the plunger to remove extra air and bubbles. To be sure you end up with 1.0 ml of bulevirtide in the syringe, you may need
to pull the plunger past the 1.0 ml mark. Carefully remove the needle and syringe from the vial. Remove the longer needle from the syringe and dispose of it properly so that nobody can be injured. Important! Do not put the plastic cap back on the needle.

3E 3F 3G 3H Attach needle for injection Choose the injection site Prepare injection site Inject bulevirtide Place the shorter needle on the syringe.
Important! Be sure the capped needle is tight by pushing it down slightly while twisting it clockwise.

Pull off the plastic cap.

Choose a site different from the one you used for your last injection. Clean the injection site with a new alcohol pad. Start in the centre, apply pressure and clean in a circular motion, working outward.
Important! Allow site to air-dry.

Pinch and hold a fold of skin around the injection site.

Pierce the skin at a 45- degree angle. The needle should be inserted most of the way in. Slowly push the plunger all the way to inject bulevirtide. Remove the needle from skin. Remove the needle from the syringe and dispose of both properly so that nobody can be injured (see 3D).