Patient information: uses, side effects, how to take - Prevymis

What is PREVYMIS?

PREVYMIS is a prescription medicine used to help prevent:

cytomegalovirus (CMV) infection and disease in adults and children 6 months and older weighing at least 13.2 pounds (lbs) or 6 kilograms (kg) who:
- have received an allogeneic hematopoietic stem cell (bone marrow) transplant, and
- have a high risk for getting CMV infection and disease.
CMV disease in adults and children 12 years of age and older weighing at least 88.2 lbs (40 kg) who:
- have received a kidney transplant, and
- have a high risk for getting CMV disease.

It is not known if PREVYMIS is safe and effective in:

children under 6 months of age or weighing less than 13.2 lbs (6 kg) who received a hematopoietic stem cell transplant, or
children under 12 years of age or weighing less than 88.2 lbs (40 kg) who received a kidney transplant.

Who should not take PREVYMIS?

Do not take PREVYMIS if you take:

pimozide
ergot alkaloids

If you are taking PREVYMIS with cyclosporine, do not take:

pitavastatin or simvastatin

What should I tell my healthcare provider before taking PREVYMIS?

Before taking PREVYMIS, tell your healthcare provider about all your medical conditions, including if you:

have kidney or liver problems.
are pregnant or plan to become pregnant. It is not known if PREVYMIS will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if PREVYMIS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking PREVYMIS.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. PREVYMIS may affect the way other medicines work, and other medicines may affect how PREVYMIS works and cause serious side effects.

Know the medicines you take. Keep a list of medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider or pharmacist will tell you if it is safe to take PREVYMIS with other medicines. Do not start or stop taking another medicine without telling your healthcare provider first.

How should I take PREVYMIS?

PREVYMIS comes as a tablet, oral pellets, or can be given by your healthcare provider through an IV line (intravenously).
PREVYMIS given intravenously should be used only if you are unable to take PREVYMIS tablets or PREVYMIS oral pellets. You should switch to PREVYMIS tablets or PREVYMIS oral pellets as soon as you are able to.
Take PREVYMIS tablets or oral pellets exactly as your healthcare provider tells you to take it. Do not stop taking PREVYMIS without talking to your healthcare provider first.
Take PREVYMIS tablets or oral pellets 1 time a day.
It is important that you do not miss or skip doses of PREVYMIS.
If you miss a dose of PREVYMIS tablets or oral pellets, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take your dose at the next scheduled time. Do not take 2 doses of PREVYMIS at the same time or take more than your prescribed dose to make up for a missed dose.
If you take too much PREVYMIS tablets or oral pellets, call your healthcare provider right away.

If you take PREVYMIS tablets:
- Take PREVYMIS with or without food.
- Swallow PREVYMIS tablets whole.
If you take PREVYMIS oral pellets:
- Your healthcare provider will tell you the number of PREVYMIS oral pellet packets to take for your prescribed dose.
- PREVYMIS oral pellets can be taken by mouth after mixing with soft food or given through a nasogastric tube (NG tube) or gastric tube (G tube).
- See the Instructions for Use for the right way to prepare and take a dose of PREVYMIS oral pellets. Keep the Instructions for Use and follow it each time you prepare and take PREVYMIS oral pellets.
- Do not crush or chew PREVYMIS oral pellets.
If you receive PREVYMIS through an IV line (intravenously):
- You will receive PREVYMIS 1 time each day given over 1 hour.
- If you miss or skip your dose of PREVYMIS, call your healthcare provider right away.

What are the possible side effects of PREVYMIS?

The most common side effects of PREVYMIS in adults who have received a hematopoietic stem cell transplant include:

nausea
diarrhea
vomiting
swelling in your arms and legs

cough
headache
tiredness
stomach (abdominal) pain

The most common side effect of PREVYMIS in adults who have received a kidney transplant is diarrhea.

The side effects of PREVYMIS in children are similar to the side effects in adults.

These are not all the possible side effects of PREVYMIS.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store PREVYMIS?

Store PREVYMIS tablets, PREVYMIS oral pellets, and PREVYMIS injection at room temperature between 68°F to 77°F (20°C to 25°C).
Store PREVYMIS tablets in the original package until you are ready to take it to protect from moisture.
Store PREVYMIS oral pellets in the original packet until you are ready to take them.
Store PREVYMIS injection in the original carton to protect from exposure to light.

Keep PREVYMIS and all medicines out of the reach of children.

General information about the safe and effective use of PREVYMIS.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use PREVYMIS for a condition for which it was not prescribed. Do not give PREVYMIS to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about PREVYMIS that is written for healthcare professionals.

What are the ingredients in PREVYMIS?

Active ingredient: letermovir

Inactive ingredients:

Tablets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone 25.

Film coating: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. Carnauba wax is added as a polishing agent.

Oral Pellets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone K-29/32.

Film coating: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.

Injection: hydroxypropyl betadex, sodium chloride, sodium hydroxide, and Water for Injection.

Important: Read this booklet first

INSTRUCTIONS FOR USE

PREVYMIS^®[PREH-vih-miss]

(letermovir)

oral pellets

This Instructions for Use contains information

on how to take PREVYMIS oral pellets.

Table of Contents

Important information you need to know before taking PREVYMIS oral pellets
Taking PREVYMIS oral pellets
- Mixing PREVYMIS oral pellets with soft food
- Giving PREVYMIS oral pellets through a gastric tube (G tube) or nasogastric tube (NG tube)
Storing PREVYMIS oral pellets packets
Learn more about PREVYMIS oral pellets

Important information you need to know before taking PREVYMIS oral pellets

Take PREVYMIS oral pellets exactly as instructed by your healthcare provider.
Take PREVYMIS oral pellets 1 time a day.
Your healthcare provider will tell you the number of PREVYMIS oral pellets packets to take for your prescribed dose.
Make sure you take your entire dose of PREVYMIS oral pellets each time.
Do not crush or chew PREVYMIS oral pellets.
Do not miss or skip doses of PREVYMIS oral pellets.
If you miss a dose of PREVYMIS oral pellets, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take your dose at the next scheduled time. Do not take 2 doses of PREVYMIS oral pellets at the same time or take more than your prescribed dose to make up for a missed dose.
If you take too much PREVYMIS oral pellets, call your healthcare provider right away.

Taking PREVYMIS oral pellets

PREVYMIS oral pellets can be taken by mouth after mixing with soft food or given through a gastric tube (G tube) or nasogastric tube (NG tube). Talk to your healthcare provider about which way to take PREVYMIS oral pellets.

Follow 1 of these ways to take PREVYMIS oral pellets:

Mix PREVYMIS oral pellets with soft food and take by mouth – go to page 5.
Give PREVYMIS oral pellets through a gastric tube (G tube) or nasogastric tube (NG tube) – go to page 13.

Mixing PREVYMIS oral pellets with soft food

Important information about mixing PREVYMIS oral pellets with soft food

	You can mix PREVYMIS oral pellets with soft food (such as applesauce, yogurt, or pudding) that is at or below room temperature. Do not use hot food.
	You must take all of the PREVYMIS oral pellets mixture within 10 minutes of mixing PREVYMIS oral pellets with the soft food. Throw away the PREVYMIS oral pellets mixed with soft food if you do not take it within 10 minutes, and prepare a new dose.

	Step 1: Wash your hands with soap and water. Dry your hands.
	Step 2: Check the expiration date located on the top of the carton. Do not use if PREVYMIS oral pellets is expired.
	Step 3: Check the pharmacy label for the number of PREVYMIS oral pellets packets needed for your dose.
	Step 4: Gather all of your supplies on a clean surface: the number of packets according to Step 3 scissors small bowl teaspoon (small spoon) Step 5: Pick a soft food that you enjoy (such as applesauce, yogurt, or pudding). Soft food should be at or below room temperature. Do not use hot food.
	Step 6: Put 1 to 3 teaspoons (small spoons) of soft food into the small bowl.
	Step 7: Tap the packets to loosen the pellets to the bottom of the packets. Hold the packets with the dotted line at the top.
	Step 8: Cut open the packets with scissors at the dotted line.
	Step 9: Lightly tap the packets to carefully sprinkle all of the PREVYMIS oral pellets onto the soft food in the same small bowl. Make sure all of the pellets go into the small bowl. Make sure the packets are empty.
	Step 10: Use the teaspoon to gently mix the food and PREVYMIS oral pellets together.
	Step 11: Take or give all of the PREVYMIS oral pellets mixture. When finished, check to make sure that no PREVYMIS oral pellets are left in the bowl or on the teaspoon. If there are PREVYMIS oral pellets left in the bowl or on the teaspoon, add more soft food, mix, and take or give the remaining mixture. If you are hungry, you can eat more food or a meal afterwards.

Take or give all of the PREVYMIS oral pellets mixture within 10 minutes of mixing PREVYMIS oral pellets with the soft food.

Throw away the PREVYMIS oral pellets mixed with soft food if you do not take it within 10 minutes, and prepare a new dose.

Step 12: Cleaning up

Throw the empty packets into the trash.
Wash the small bowl and teaspoon with soap and water.
Put everything in a clean, dry place.

Go to page 28 for Storing PREVYMIS oral pellets packets and page 32 to Learn more about PREVYMIS oral pellets.

Giving PREVYMIS oral pellets through a gastric tube (G tube) or nasogastric tube (NG tube)

These instructions are for giving PREVYMIS oral pellets through a G tube or NG tube.

Gastric tube

(G tube)

Nasogastric tube

(NG tube)

Ask your healthcare provider how to give PREVYMIS oral pellets through a G tube or NG tube and how to clean the G tube or NG tube.

Ask your healthcare provider how to flush the G tube or NG tube before taking or giving a dose of PREVYMIS oral pellets.

Your healthcare provider will tell you how much water to use.

Giving PREVYMIS oral pellets through a G tube or NG tube

Important information you need to know before mixing PREVYMIS oral pellets with water

	Mix PREVYMIS oral pellets with room temperature water. Do not mix PREVYMIS oral pellets with hot or cold (refrigerated) water. After you mix PREVYMIS oral pellets with room temperature water, you must wait at least 10 minutes before giving it. This allows the PREVYMIS oral pellets to become loose or broken up. After 10 minutes, give the PREVYMIS oral pellets mixture through the G tube or NG tube. If you do not give the PREVYMIS oral pellets mixture within 2 hours, throw away the PREVYMIS oral pellets mixture and start over.
	Step 1: Wash your hands with soap and water. Dry your hands.
	Step 2: Check the expiration date located on the top of the carton. Do not use if PREVYMIS oral pellets is expired.
	Step 3: Check the pharmacy label for the number of PREVYMIS oral pellets packets needed for your dose.
	Step 4: Gather all your supplies on a clean surface: the number of PREVYMIS oral pellets packets according to Step 3 scissors clock or timer small glass syringe provided by your healthcare provider or pharmacist medicine cup (15 to 30 mL) provided by your healthcare provider or pharmacist
	Step 5: Pour a small amount of room temperature water into the small glass. Do not use hot or cold (refrigerated) liquid.
	Step 6: Place the tip of the syringe into the small glass of room temperature water. Pull up on the syringe plunger to measure the amount of water needed for your dose. Your healthcare provider will tell you how much water you need for your dose.
	Step 7: Add the water to the medicine cup by holding the barrel of the syringe and pushing the syringe plunger all the way down.
	Step 8: Tap the packets to loosen the pellets to the bottom of the packets. Hold the packets with the dotted line at the top.
	Step 9: Cut open the packets with scissors at the dotted line.
	Step 10: Lightly tap the packets to carefully pour the PREVYMIS oral pellets into the same medicine cup. Make sure all of the PREVYMIS oral pellets go into the medicine cup. Make sure the packets are empty.
	Step 11: Use a clock or timer and wait 10 minutes. Do not shake or swirl the medicine cup.

Important: While waiting, keep the medicine cup in a safe place out of reach of children.

	PREVYMIS oral pellets will not dissolve but will become loose or broken up. After 10 minutes, the PREVYMIS oral pellets mixture will be ready to use. Follow Steps 12-19 to give the PREVYMIS oral pellets mixture through the G tube or NG tube.
	Step 12: Gently stir the PREVYMIS oral pellets mixture with the syringe tip. Do not shake or swirl the medicine cup.
	Step 13: Tilt the medicine cup and pull up on the syringe plunger to draw up all of the PREVYMIS oral pellets mixture from the medicine cup. Give the PREVYMIS oral pellets mixture right away after it is drawn up into the syringe.
	Step 14: Give the PREVYMIS oral pellets mixture. Gently turn the syringe upside down (invert) to keep the medicine from settling. Do not shake the syringe since this can cause air bubbles. Attach the syringe to the G tube or NG tube. Slowly push on the plunger to move the mixture through the G tube or NG tube.

	Step 15: Use the same syringe to withdraw more water from the small glass. Your healthcare provider will tell you how much water to use to rinse the G tube or NG tube.
	Step 16: Slowly push the syringe plunger all the way down to add the water in the syringe into the same medicine cup.
	Step 17: Gently stir the rinse mixture with the syringe tip. Do not shake or swirl the medicine cup.
	Step 18: Tilt the medicine cup and pull up on the syringe plunger to draw up all of the rinse mixture from the medicine cup.
	Step 19: Give the rinse mixture. Gently turn the syringe upside down (invert) to keep the medicine from settling. Do not shake the syringe since this can cause air bubbles. Attach the syringe to the G tube or NG tube. Slowly push the plunger all the way down to move the rinse mixture through the G tube or NG tube.

Step 20: Flush the G tube or NG tube right away using water.

Ask your healthcare provider how much water to use.

Step 21: Cleaning up

Throw the empty packets into the trash.
Hand wash the syringe and medicine cup with warm water and dish soap.
- Do not wash the syringe and medicine cup in the dishwasher.
- Do not boil the syringe and medicine cup.
Put everything in a clean, dry place.

Go to page 28 for Storing PREVYMIS oral pellets packets and page 32 to Learn more about PREVYMIS oral pellets.

Storing PREVYMIS oral pellets packets

Store PREVYMIS oral pellets at room temperature between 68°F to 77°F (20°C to 25°C).
Store PREVYMIS oral pellets in the original packet until you are ready to take them.
Keep PREVYMIS oral pellets and all medicine out of the reach of children.

Learn more about PREVYMIS oral pellets

For more information on how to use PREVYMIS oral pellets, ask your healthcare provider or pharmacist and read the PREVYMIS Patient Information.

For more information about PREVYMIS oral pellets, go to PREVYMIS.com or call 1-800-444-2080.

Distributed by:

Merck Sharp & Dohme LLC

Rahway, NJ 07065, USA

usifu-mk8228-op-2408r000

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Approved: 08/2024

Prevymis (Letermovir): Uses, Side Effects and Dosage