Pronunciation:

ro-peg-in-ter-FEER-on AL-fa-too-bee - njft

Brand Names:

• BESREMi

Dosage Forms:

• Solution

Warnings:

Risk of Serious DisordersInterferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy .

Classifications:

Pharmacologic—

Ropeginterferon Alfa-2b

Uses of This Medicine:

Ropeginterferon alfa-2b-njft injection is used to treat polycythemia vera.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ropeginterferon alfa-2b-njft injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ropeginterferon alfa-2b-njft injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acepromazine
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aripiprazole
• Aripiprazole Lauroxil
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Droperidol
• Enflurane
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Levocetirizine
• Levorphanol
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Olanzapine
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Secobarbital
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Blood or bone marrow problems (eg, anemia, low white blood cells) or
• Depression, or history of or
• Eye problems or
• Heart or blood vessel disease, history of
• Immune system problems (eg, autoimmune disease, weakened immune system)
• Lung or breathing problems or
• Thyroid problems or
• Type I diabetes—Use with caution. May make these conditions worse.

• Heart or blood vessel disease (eg, congestive heart failure, heart attack, stroke), severe or
• Heart rhythm problems, severe or
• Hypertension (uncontrolled) or
• Liver disease, moderate to severe or
• Mental health problems (eg, depression, thoughts of suicide) or
• Patients who received a transplant and take medicines that weaken immune system or
• Serious or untreated autoimmune disorders, active or history of—Should not be used in patients with these conditions.

• Infections—May decrease your body's ability to fight infections.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin (usually in the lower stomach area or upper part of the thigh).

If you are injecting ropeginterferon alfa-2b-njft yourself, use it exactly as directed by your doctor. Do not change your dose or dosing schedule without checking first with your doctor. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk for side effects, while using too little may not improve your condition.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are irritated, reddened, bruised, infected, or scarred in any way.

Each package of the medicine contains a Medication Guide and patient instructions. Read the instructions carefully and make sure you understand:

• How to prepare the injection.
• How to use prefilled syringes.
• How to store the prefilled syringes.

Check the medicine in the prefilled syringe. The liquid should be clear and colorless to slightly yellow. Do not use the medicine if it is cloudy, discolored, or has particles in it. Do not use the prefilled syringe if it is damaged or broken.

Allow the medicine to warm to room temperature for 15 to 30 minutes before you use it. Do not warm it in any other way.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For polycythemia vera (patients not using hydroxyurea):
    • Adults—At first, 100 micrograms (mcg) injected under your skin every 2 weeks. Your doctor may gradually increase your dose 50 mcg every 2 weeks.
    • Children—Use and dose must be determined by your doctor.
  • For polycythemia vera (patients receiving hydroxyurea):
    • Adults—At first, 50 micrograms (mcg) injected under your skin every 2 weeks in combination with hydroxyurea. Your doctor may gradually increase your dose 50 mcg and gradually reduce hydroxyurea every 2 weeks during weeks 3 to 12.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Do not use this medicine if it has been frozen or left in direct sunlight.

Each prefilled syringe or needle should be used only one time. Do not reuse your prefilled syringe or needle. Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 8 weeks after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause some people to be anxious, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if you have blurred vision, chest pain, confusion, lightheadedness, dizziness, or fainting, fast or irregular heartbeat, sudden fainting, trouble breathing, or unusual tiredness or weakness. These may be symptoms of serious heart problems.

This medicine may lower the number of white blood cells in the blood. This will increase your chance of getting an infection. It can also lower the number of platelets in the blood. Platelets are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Pancreatitis (swelling of the pancreas) may occur while using this medicine. Check with your doctor right away if you have bloating, sudden and severe stomach pain, chills, constipation, nausea, pains in stomach, side, or abdomen, possibly radiating to the back, vomiting, fever, or lightheadedness, or yellow eyes or skin.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 12 weeks or more after you start using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may increase the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause tooth and gum problems, which can lead to tooth loss. It may also cause dry mouth, which may cause teeth or mouth problems, if you take this medicine for a lone time. Brush your teeth well (2 times a day) and have regular visits to your dentist during treatment with this medicine.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

This medicine may cause dizziness, drowsiness, or seeing, hearing, or feeling things that are not there. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may affect your menstrual cycles. Talk with your doctor if you have any concerns about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

bleeding gyms

blindness

blood in the urine or stools

blurred vision

bone pain

chest pain

chills

cough

decreased vision

diarrhea

discouragement

dizziness

dry eyes

ear congestion

feeling sad or empty

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

itching skin

joint pain

loss of appetite

loss of interest or pleasure

loss of voice

loss or thinning of the hair

lower back or side pain

muscle aches and pains

nausea

nervousness

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

shivering

slow or fast heartbeat

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stuffy or runny nose

sweating

swelling

swollen glands

trouble breathing

trouble concentrating

trouble sleeping

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Less common

Bloating

constipation

darkened urine

dry skin and hair

fainting

feeling cold

hoarseness or husky voice

indigestion

muscle cramps and stiffness

pains in the stomach, side, or abdomen, possibly radiating to the back

sensitivity to heat

weight gain or loss

yellow eyes or skin

Rare

Agitation

coma

confusion

decreased urine output

irritability

lethargy

muscle twitching

seizures

stupor

swelling of the face, ankles, or hands

Incidence not known

Change in vision

chest tightness

difficulty swallowing

dry mouth

hives, itching, skin rash

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

noisy breathing

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

tooth loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty in moving

feeling of constant movement of self or surroundings

increased sweating

lack or loss of strength

muscle spasm or stiffness

pain in the joints

red streaks on the skin

sensation of spinning

swelling, tenderness, or pain at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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