ISENTRESS (Page 8 of 8)

14.4 Pediatric Subjects

2 to 18 Years of Age

IMPAACT P1066 is a Phase I/II open label multicenter trial to evaluate the pharmacokinetic profile, safety, tolerability, and efficacy of raltegravir in HIV infected children. This study enrolled 126 treatment experienced children and adolescents 2 to 18 years of age. Subjects were stratified by age, enrolling adolescents first and then successively younger children. Subjects were enrolled into cohorts according to age and received the following formulations: Cohort I (12 to less than 18 years old), 400 mg film-coated tablet; Cohort IIa (6 to less than 12 years old), 400 mg film-coated tablet; Cohort IIb (6 to less than 12 years old), chewable tablet; Cohort III (2 to less than 6 years), chewable tablet. Raltegravir was administered with an optimized background regimen.

The initial dose finding stage included intensive pharmacokinetic evaluation. Dose selection was based upon achieving similar raltegravir plasma exposure and trough concentration as seen in adults, and acceptable short term safety. After dose selection, additional subjects were enrolled for evaluation of long term safety, tolerability and efficacy. Of the 126 subjects, 96 received the recommended dose of ISENTRESS [see Dosage and Administration (2.3)] .

These 96 subjects had a median age of 13 (range 2 to 18) years, were 51% Female, 34% Caucasian, and 59% Black. At baseline, mean plasma HIV-1 RNA was 4.3 log 10 copies/mL, median CD4 cell count was 481 cells/mm 3 (range: 0 – 2361) and median CD4% was 23.3% (range: 0 – 44). Overall, 8% had baseline plasma HIV-1 RNA >100,000 copies/mL and 59% had a CDC HIV clinical classification of category B or C. Most subjects had previously used at least one NNRTI (78%) or one PI (83%).

Ninety-three (97%) subjects 2 to 18 years of age completed 24 weeks of treatment (3 discontinued due to non-compliance). At Week 24, 54% achieved HIV RNA <50 copies/mL; 66% achieved HIV RNA <400 copies/mL. The mean CD4 count (percent) increase from baseline to Week 24 was 119 cells/mm 3 (3.8%).

4 Weeks to Less Than 2 Years of Age

IMPAACT P1066 also enrolled HIV-infected, infants and toddlers 4 weeks to less than 2 years of age (Cohorts IV and V) who had received prior antiretroviral therapy either as prophylaxis for prevention of mother-to-child transmission (PMTCT) and/or as combination antiretroviral therapy for treatment of HIV infection. Raltegravir was administered as an oral suspension without regard to food in combination with an optimized background regimen.

The 26 subjects had a median age of 28 weeks (range: 4 -100), were 35% female, 85% Black and 8% Caucasian. At baseline, mean plasma HIV-1 RNA was 5.7 log 10 copies/mL (range: 3.1 – 7), median CD4 cell count was 1400 cells/mm 3 (range: 131 – 3648) and median CD4% was 18.6% (range: 3.3 – 39.3). Overall, 69% had baseline plasma HIV-1 RNA exceeding 100,000 copies/mL and 23% had a CDC HIV clinical classification of category B or C. None of the 26 subjects were completely treatment naïve. All infants under 6 months of age had received nevirapine or zidovudine for prevention of mother-to-infant transmission, and 43% of subjects greater than 6 months of age had received two or more antiretrovirals.

Of the 26 treated subjects, 23 subjects were included in the Week 24 and 48 efficacy analyses, respectively. All 26 treated subjects were included for safety analyses.

At Week 24, 39% achieved HIV RNA <50 copies/mL and 61% achieved HIV RNA <400 copies/mL. The mean CD4 count (percent) increase from baseline to Week 24 was 500 cells/mm 3 (7.5%).

At Week 48, 44% achieved HIV RNA <50 copies/mL and 61% achieved HIV RNA <400 copies/mL. The mean CD4 count (percent) increase from baseline to Week 48 was 492 cells/mm 3 (7.8%).

16 HOW SUPPLIED/STORAGE AND HANDLING

ISENTRESS tablets 400 mg are pink, oval-shaped, film-coated tablets with “227” on one side. They are supplied as follows:

  • NDC 0006-0227-61 unit-of-use bottles of 60.
  • No. 3894

ISENTRESS HD tablets 600 mg are yellow, oval-shaped, film-coated tablets with Merck logo and “242” on one side and plain on the other side. They are supplied as follows:

  • NDC 0006-3080-01 unit-of-use bottles of 60.
  • No. 3080

ISENTRESS tablets 100 mg are pale orange, oval-shaped, orange-banana flavored, chewable tablets scored on both sides and imprinted on one face with the Merck logo and “477” on opposite sides of the score. They are supplied as follows:

  • NDC 0006-0477-61 unit-of-use bottles of 60.
  • No. 3972

ISENTRESS tablets 25 mg are pale yellow, round, orange-banana flavored, chewable tablets with the Merck logo on one side and “473” on the other side. They are supplied as follows:

  • NDC 0006-0473-61 unit-of-use bottles of 60.
  • No. 3965

ISENTRESS for oral suspension 100 mg is a white to off-white granular powder that may contain yellow or beige to tan particles, in child resistant single-use foil packets, packaged as

A kit with two 5 mL dosing syringes and two mixing cups.

It is supplied as follows:

  • NDC 0006-3603-60 unit of use carton with 60 packets.
  • NDC 0006-3603-01 individual packet.
  • No. 3603

or

A kit with two 1 mL syringes, two 3 mL syringes, two 10 mL syringes and two mixing cups. It is supplied as follows:

  • NDC 0006-3603-61 unit of use carton with 60 packets.
  • NDC 0006-3603-01 individual packet.

Storage and Handling

400 mg Film-coated Tablets, 600 mg Film-coated Tablets, Chewable Tablets and For Oral Suspension

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

400 mg Film-coated Tablets, 600 mg Film-coated Tablets and Chewable Tablets

Store in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture.

For Oral Suspension

Store in the original container. Do not open foil packet until ready for use.

17 PATIENT COUNSELING INFORMATION

Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Severe and Potentially Life-threatening Rash

Inform patients that severe and potentially life-threatening rash has been reported. Advise patients to immediately contact their healthcare provider if they develop rash. Instruct patients to immediately stop taking ISENTRESS or ISENTRESS HD and other suspect agents, and seek medical attention if they develop a rash associated with any of the following symptoms as it may be a sign of a more serious reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis or severe hypersensitivity: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral lesions, eye inflammation, facial swelling, swelling of the eyes, lips, mouth, breathing difficulty, and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on the right side below the ribs). Inform patients that if severe rash occurs, their physician will closely monitor them, order laboratory tests and initiate appropriate therapy.

Immune Reconstitution Syndrome

Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.2)] .

Rhabdomyolysis

Before patients begin ISENTRESS or ISENTRESS HD, ask them if they have a history of rhabdomyolysis, myopathy or increased creatine kinase or if they are taking medications known to cause these conditions such as statins, fenofibrate, gemfibrozil or zidovudine [see Adverse Reactions (6.1)] .

Instruct patients to immediately report to their healthcare provider any unexplained muscle pain, tenderness, or weakness while taking ISENTRESS.

Phenylketonuria

Alert patients with phenylketonuria that ISENTRESS Chewable Tablets contain phenylalanine [see Warnings and Precautions (5.3)].

Drug Interactions

Inform patients that ISENTRESS or ISENTRESS HD may interact with some drugs and ask them to identify all their current medications including over-the-counter agents [see Drug Interactions (7.2)] .

Missed Dosage

Inform patients that it is important to take ISENTRESS or ISENTRESS HD on a regular dosing schedule as instructed by their healthcare provider and to avoid missing doses as it can result in development of resistance [see Dosage and Administration (2)].

Important Administration Instructions

Film-Coated Tablets and Chewable Tablets

Inform patients that the chewable tablets can be chewed or swallowed whole, but the film-coated tablets must be swallowed whole.

For Oral Suspension

Instruct parents and/or caregivers to read the Instructions for Use before preparing and administering ISENTRESS for oral suspension to pediatric patients. Instruct parents and/or caregivers that ISENTRESS for oral suspension should be administered within 30 minutes of mixing.

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ISENTRESS or ISENTRESS HD during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)].

Distributed by:
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2014-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

uspi-mk0518-mf-1901r034

PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised November 2017
ISENTRESS ® (eye sen tris) (raltegravir) film-coated tablets ISENTRESS ® (eye sen tris) (raltegravir) chewable tablets
ISENTRESS ® HD (eye sen tris HD) (raltegravir) film-coated tablets ISENTRESS ® (eye sen tris) (raltegravir) for oral suspension
What are ISENTRESS and ISENTRESS HD?
ISENTRESS is a prescription HIV medicine used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults, and in children weighing at least 4.4 pounds (2 kg). HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
ISENTRESS HD is a prescription HIV medicine used with other antiretroviral medicines to treat HIV-1 infection in adults, and in children weighing at least 88 pounds (40 kg). ISENTRESS should not be used in children who weigh less than 4.4 pounds (2 kg).
Before you take ISENTRESS or ISENTRESS HD, tell your doctor about all of your medical conditions, including if you:
  • have liver problems
  • have a history of a muscle disorder called rhabdomyolysis or myopathy
  • have increased levels of creatine kinase in your blood
  • have phenylketonuria (PKU). ISENTRESS chewable tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU.
  • receive kidney dialysis treatment
  • are pregnant or plan to become pregnant. It is not known if ISENTRESS or ISENTRESS HD can harm your unborn baby. Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take ISENTRESS or ISENTRESS HD .
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • It is not known if ISENTRESS or ISENTRESS HD can pass into your breast milk.
    • Talk with your doctor about the best way to feed your baby.
Tell your doctor about all the medicines you take, including, prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with ISENTRESS and ISENTRESS HD.
  • Keep a list of your medicines to show your doctor and pharmacist.
  • You can ask your doctor or pharmacist for a list of medicines that interact with ISENTRESS and ISENTRESS HD.
  • Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take ISENTRESS or ISENTRESS HD with other medicines.
How should I take ISENTRESS or ISENTRESS HD?
  • Take ISENTRESS or ISENTRESS HD exactly as prescribed by your doctor.
  • Do not change your dose of ISENTRESS or ISENTRESS HD or stop your treatment without talking with your doctor first.
  • Stay under the care of your doctor during treatment with ISENTRESS or ISENTRESS HD.
  • ISENTRESS film-coated tablets and ISENTRESS HD film-coated tablets must be swallowed whole.
  • ISENTRESS chewable tablets may be chewed or swallowed whole.
  • Do not switch between the film-coated tablet, the chewable tablet, or the oral suspension without talking with your doctor first.
  • Do not switch between the ISENTRESS 400 mg film-coated tablet and the ISENTRESS HD 600 mg film-coated tablet if your prescribed dose is 1200 mg.
  • Do not run out of ISENTRESS or ISENTRESS HD. The virus in your blood may increase and the virus may become harder to treat. Get a refill of your ISENTRESS or ISENTRESS HD from your doctor or pharmacy before you run out.
  • Take ISENTRESS or ISENTRESS HD on a regular dosing schedule as instructed by your doctor. Do not miss doses.
  • If you take too much ISENTRESS or ISENTRESS HD, call your doctor or go to the nearest hospital emergency room right away.

If ISENTRESS for oral suspension is prescribed for your child, be sure to read the following information:

  • Before giving the first dose of ISENTRESS for oral suspension, read the Instructions for Use booklet that comes with ISENTRESS for oral suspension for information about the correct way to mix and give a dose of ISENTRESS for oral suspension to your child. Keep the booklet and follow it each time you prepare the medicine. Bring this booklet to your child’s appointments.
  • Make sure your doctor shows you how to mix and give the right dose of ISENTRESS for oral suspension to your child. If you have questions about how to mix or give ISENTRESS for oral suspension, talk with your doctor or pharmacist.
  • Give the dose of ISENTRESS for oral suspension within 30 minutes of mixing.
  • If your child does not take all of the prescribed dose or spits some of it out, call your doctor to find out what to do.
  • Your child’s dose will change over time. Make sure you follow your doctor’s instructions. Your doctor will tell you if and when to stop giving ISENTRESS to your child.
What are the possible side effects of ISENTRESS or ISENTRESS HD?
ISENTRESS and ISENTRESS HD can cause serious side effects including:
  • Severe skin reactions and allergic reactions. Some people who take ISENTRESS or ISENTRESS HD develop severe skin reactions and allergic reactions that can be serious, and may be life-threatening or lead to death.
    • If you develop a rash, call your doctor right away.
    • If you develop a rash with any of the following symptoms, stop using ISENTRESS or ISENTRESS HD and call your doctor or get medical help right away:
  • fever
  • generally ill feeling
  • extreme tiredness
  • muscle or joint aches
  • blisters or sores in mouth
  • blisters or peeling of the skin
  • redness or swelling of the eyes
  • swelling of the mouth, lips, or face
  • problems breathing
Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor right away if you have any of the following signs or symptoms of liver problems:
  • yellowing of your skin or whites of your eyes
  • dark or tea colored urine
  • pale colored stools (bowel movements)
  • nausea or vomiting
  • loss of appetite
  • pain, aching, or tenderness on the right side of your stomach area
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV-1 medicine.
The most common side effects of ISENTRESS and ISENTRESS HD include:
  • trouble sleeping
  • headache
  • dizziness
  • nausea
  • tiredness
Less common side effects of ISENTRESS and ISENTRESS HD include:
  • depression
  • hepatitis
  • genital herpes
  • herpes zoster including shingles
  • kidney failure
  • kidney stones
  • indigestion or stomach area pain
  • vomiting
  • suicidal thoughts and actions
  • weakness
Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness during treatment with ISENTRESS or ISENTRESS HD. These may be signs of a rare serious muscle problem that can lead to kidney problems.
These are not all the possible side effects of ISENTRESS and ISENTRESS HD.
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 ISENTRESS and ISENTRESS HD?
ISENTRESS and ISENTRESS HD film-coated tablets:
  • Store ISENTRESS and ISENTRESS HD film-coated tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store ISENTRESS and ISENTRESS HD film-coated tablets in the original package with the bottle tightly closed.
  • Keep the drying agent (desiccant) in the ISENTRESS and ISENTRESS HD bottle to protect from moisture.
ISENTRESS chewable tablets:
  • Store ISENTRESS chewable tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store ISENTRESS chewable tablets in the original package with the bottle tightly closed.
  • Keep the drying agent (desiccant) in the bottle to protect from moisture.
ISENTRESS for oral suspension:
  • Store ISENTRESS for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store in the original container. Do not open the foil packet until ready for use.
Keep ISENTRESS and all medicines out of the reach of children.
General information about the safe and effective use of ISENTRESS and ISENTRESS HD
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet.
Do not use ISENTRESS or ISENTRESS HD for a condition for which it was not prescribed. Do not give ISENTRESS or ISENTRESS HD to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about ISENTRESS or ISENTRESS HD that is written for health professionals.
What are the ingredients in ISENTRESS and ISENTRESS HD?
ISENTRESS 400 mg film-coated tablets:
Active ingredient: raltegravir
Inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate.
The film coating contains: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide.
ISENTRESS HD 600 mg film-coated tablets:
Active ingredient: raltegravir
Inactive ingredients: croscarmellose sodium, hypromellose 2910, magnesium stearate, microcrystalline cellulose.
The film coating contains: ferrosoferric oxide, hypromellose 2910, iron oxide yellow, lactose monohydrate, triacetin and titanium dioxide.
The tablet may also contain trace amount of carnauba wax.
ISENTRESS chewable tablets:
Active ingredient: raltegravir
Inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. The 100 mg chewable tablet also contains red iron oxide.
ISENTRESS for oral suspension:
Active ingredient: raltegravir
Inactive ingredients: ammonium hydroxide, banana with other natural flavors, carboxymethylcellulose sodium, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, microcrystalline cellulose, monoammonium glycyrrhizinate, oleic acid, sorbitol, sucralose and sucrose.
Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright © 2007-2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.
usppi-mk0518-mf-1711r028 For more information go to www.ISENTRESS.com or call 1-800-622-4477.

Bring this booklet to your child’s appointments.

ISENTRESS (raltegravir) for oral suspension

Instructions for Use

for babies and toddlers

Figure
(click image for full-size original)

Before You Start

Note: Make sure your doctor shows you how to prepare and give ISENTRESS for oral suspension.
  • Be sure you understand these instructions before you start. Call your doctor if you have any questions.
  • It is very important that you measure the water and ISENTRESS carefully using the correct syringe.
  • Before you give ISENTRESS to your child, check the expiration date. The expiration date is printed on the box and the ISENTRESS packets.
  • Do not open the ISENTRESS packets until you are ready to mix a dose.
  • The amount of ISENTRESS depends on your child’s age and weight, so it will change over time.
    Your doctor will tell you the right dose at each check-up after weighing your child.
    Be sure to keep your doctor’s appointments so you get new dosing information as your child grows. During your child’s first week of life, you will give ISENTRESS 1 time a day. After the first week of life, you will give it 2 times a day.
  • This booklet tells you how to:
    • Mix ISENTRESS into a liquid form
    • Measure the right dose using a syringe
    • Give mixed ISENTRESS to your child
    • Clean up

Kit Contents

  • Prescription (on box)
Figure
  • 2 mixing cups
Figure
  • Instructions for Use (this booklet)
  • Prescribing Information
  • 6 syringes
Figure
  • 60 packets of ISENTRESS
Figure
FigureFigureFigure
2 blue (10mL) syringes 2 green (3mL) syringes 2 white (1mL) syringes

The kit has an extra cup and set of syringes in case one is lost or damaged.

Do not use any damaged cups or syringes.

Step 1. Get ready

  • Put your child in a safe place. You will need both hands to prepare ISENTRESS.
  • Wash your hands with soap and water.
  • Take out what you need from the kit as shown below to make 1 dose and place on a clean surface:
FigureFigureFigureFigure
1 mixing cup (Using the tab on the mixing cup, pull open the lid) 1 packet of ISENTRESSa clean glass3 syringes (Have one of each size ready, but you will only need 1 or 2, depending on the prescribed dose)

Step 2. Fill a clean glass with water

Fill a clean glass with room-temperature drinking water from your sink or use bottled water.Figure

Step 3. Fill the blue syringe with water

Push the plunger of the blue syringe into the syringe as far as it goes.
Figure
(click image for full-size original)
Put the tip of the syringe into the glass of water. Pull back the plunger to draw up water into the syringe. Stop when you get to the 10mL mark.
Figure
(click image for full-size original)

Step 4. Check for air bubbles

Hold the syringe with tip up. Tap it with your finger to move any air bubbles up towards the tip. Slowly push up on the plunger to make the air come out. You may see some drops of water come out. Figure
FigureRe-check the amount of water in the syringe. If it is less than 10mL, put the tip back into the water and pull back on the plunger until you get to the 10mL mark.

Step 5. Add the 10mL of water to the mixing cup

Add the 10 mL of water from the syringe to the mixing cup by pushing all the way down on the plunger.

Figure
(click image for full-size original)

Step 6. Add ISENTRESS to the mixing cup

Note before adding ISENTRESS: Make sure you and your child are ready! After mixing ISENTRESS, use it within 30 minutes. Throw away any leftover ISENTRESS after you have given the dose to your child.

Figure

Take 1 packet of ISENTRESS and shake the powder to the bottom of the packet.
Tear or cut open the packet at the dotted line and add all of the powder to the water in the mixing cup. Make sure the packet is completely empty.Figure

Step 7. Mix ISENTRESS and water

Snap the lid of the mixing cup shut. Gently swirl the mixing cup for 45 seconds in a circular motion to mix the powder and water. Use a clock or timer to time for 45 seconds. Do not shake the mixture. Figure
FigureCheck to make sure the powder is mixed. If it is not mixed, swirl it some more. The mixture should look cloudy.

Step 8. Check your prescription

Find the dose amount in ‘mL’ prescribed by your doctor. This is written on the prescription label on the box from your pharmacy.

Figure
(click image for full-size original)

Remember that the dose may change each time you go to the doctor, so make sure you check the prescribed dose each time. Be sure to go to all of your doctor’s appointments so your child gets the right dose!

Step 9. Choose the syringe you need

Your doctor will prescribe the dose in milliliters (mL). Choose the right syringe for your child’s dose:

WHITE (1mL) for 1mL or less FigureGREEN (3mL) for 1.5mL to 3mL FigureBLUE (10mL) for 3.5mL to 10mL Figure

Then find the mL mark on the syringe that matches your child’s dose.

Step 10. Measure ISENTRESS

Push the plunger into the barrel of the syringe as far as it goes.Figure
Put the tip of the syringe into the cup of the mixed ISENTRESS and pull back on the plunger. Stop when you get to the line that matches your child’s prescribed dose. Figure
IMPORTANT:
  • Your child’s dose may be different from the one shown in this figure.
  • There will usually be some leftover mixed ISENTRESS in the mixing cup.

Step 11. Check for air bubbles

Hold the syringe with tip up. Tap it with your finger to move any air bubbles up towards the tip. Slowly push the plunger to make the air come out. You may see some drops of medicine come out.
Figure
(click image for full-size original)
FigureRe-check the amount of ISENTRESS in the syringe. If it is less than the prescribed dose, put the tip back into the cup of mixed ISENTRESS and pull back on the plunger until you get to the right dose mark.

Step 12. Give ISENTRESS to your child

Place the tip of the syringe inside your child’s mouth so that it touches either the right or left cheek.Figure

Slowly push in the plunger to give the dose of mixed ISENTRESS to your child. If your child fusses, take the tip of the syringe out of the mouth and try again. It is important that your child takes all of the prescribed dose (a little left in the syringe tip is OK).

IMPORTANT: If your child does not take all of the prescribed dose or spits some of it out, call your doctor to find out what to do.

Step 13. Clean up

Pour the leftover mixed ISENTRESS into the trash. Do not pour it into the sink.

Pull the plungers out of any syringes you used.

Hand wash the syringes, plungers, and mixing cup with warm water and dish soap. Do not wash in the dishwasher.

Rinse with water and let air dry. Put everything in a clean, dry place.

Figure

How should I store ISENTRESS?

Store the ISENTRESS for oral suspension kit at room temperature between 68°F to 77°F (20°C to 25°C).

Store in the original container.

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

Be sure to keep your doctor’s appointments so you always know how much ISENTRESS to give to your child.

For more information, go to www.ISENTRESS.com or call 1-800-622-4477.

Distributed by:
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Whitehouse Station, NJ, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2013-2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

ifu-mk0518-mf-1711r001 Revised November/2017

DRUG: ISENTRESS

GENERIC: RALTEGRAVIR

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-1621-0

NDC: 70518-1621-1

NDC: 70518-1621-2

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 16 mm

IMPRINT: 227

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 6 in 1 BLISTER PACK

PACKAGING: 8 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • RALTEGRAVIR POTASSIUM 400mg in 1

INACTIVE INGREDIENT(S):

  • FERRIC OXIDE RED
  • POLYETHYLENE GLYCOL 3350
  • POLYVINYL ALCOHOL, UNSPECIFIED
  • FERROSOFERRIC OXIDE
  • POLOXAMER 407
  • SODIUM STEARYL FUMARATE
  • TALC
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE
  • BUTYLATED HYDROXYTOLUENE
  • HYPROMELLOSE, UNSPECIFIED
  • MICROCRYSTALLINE CELLULOSE
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • TITANIUM DIOXIDE
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
MM3
(click image for full-size original)
ISENTRESS raltegravir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1621(NDC:0006-0227)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RALTEGRAVIR POTASSIUM (RALTEGRAVIR) RALTEGRAVIR 400 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
BUTYLATED HYDROXYTOLUENE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLOXAMER 407
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
FERRIC OXIDE RED
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink (pink) Score no score
Shape OVAL (oval-shaped) Size 16mm
Flavor Imprint Code 227
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-1621-0 30 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:70518-1621-1 6 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:70518-1621-2 8 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022145 10/31/2018
Labeler — REMEDYREPACK INC. (829572556)

Revised: 10/2019 REMEDYREPACK INC.

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