Ropeginterferon alfa-2b-njft Subcutaneous Advanced Patient Information - Drugs.com

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# Ropeginterferon alfa-2b-njft (Subcutaneous)

Medically reviewed by Drugs.com. Last updated on Jul 23, 2022.

Subcutaneous route(Solution)

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 Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions.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 .

## Commonly used brand name(s)

In the U.S.

- BESREMi

Available Dosage Forms:

- Solution

Pharmacologic Class: Ropeginterferon Alfa-2b

## Uses for ropeginterferon alfa-2b-njft

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

Ropeginterferon alfa-2b-njft is available only with your doctor's prescription.

## Before using ropeginterferon alfa-2b-njft

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 ropeginterferon alfa-2b-njft, the following should be considered:

### Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ropeginterferon alfa-2b-njft 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.

### Pediatric

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.

### Geriatric

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 ropeginterferon alfa-2b-njft.

### Breastfeeding

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.

### Interactions with 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 ropeginterferon alfa-2b-njft, 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 ropeginterferon alfa-2b-njft 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

### Interactions with food/tobacco/alcohol

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 ropeginterferon alfa-2b-njft. 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 ropeginterferon alfa-2b-njft

A nurse or other trained health professional will give you ropeginterferon alfa-2b-njft. You may also be taught how to give your medicine at home. Ropeginterferon alfa-2b-njft 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 ropeginterferon alfa-2b-njft 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 ropeginterferon alfa-2b-njft. 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 ropeginterferon alfa-2b-njft 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.

Detailed Ropeginterferon alfa-2b dosage information

## Precautions while using ropeginterferon alfa-2b-njft

It is very important that your doctor check your progress at regular visits to make sure that ropeginterferon alfa-2b-njft 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 ropeginterferon alfa-2b-njft. Using ropeginterferon alfa-2b-njft while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with ropeginterferon alfa-2b-njft and for at least 8 weeks after the last dose. If you think you have become pregnant while using ropeginterferon alfa-2b-njft, tell your doctor right away.

Ropeginterferon alfa-2b-njft 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.

Ropeginterferon alfa-2b-njft 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.

Ropeginterferon alfa-2b-njft 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 ropeginterferon alfa-2b-njft.

Pancreatitis (swelling of the pancreas) may occur while using ropeginterferon alfa-2b-njft. 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.

Ropeginterferon alfa-2b-njft may cause diarrhea, and in some cases it can be severe. It may occur 12 weeks or more after you start using ropeginterferon alfa-2b-njft. 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 ropeginterferon alfa-2b-njft. 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).

Ropeginterferon alfa-2b-njft 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.

Ropeginterferon alfa-2b-njft 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 ropeginterferon alfa-2b-njft for a lone time. Brush your teeth well (2 times a day) and have regular visits to your dentist during treatment with ropeginterferon alfa-2b-njft.

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 ropeginterferon alfa-2b-njft. 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 ropeginterferon alfa-2b-njft.

Ropeginterferon alfa-2b-njft 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 ropeginterferon alfa-2b-njft affects you.

Ropeginterferon alfa-2b-njft 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.

## Ropeginterferon alfa-2b-njft side effects

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.

Ropeginterferon alfa-2b side effects (more detail)

## More about ropeginterferon alfa-2b

- Check interactions
- Side effects
- Dosage information
- During pregnancy
- Drug class: antineoplastic interferons
- En español

### Patient resources

- Drug Information

#### Other brands

Besremi

### Professional resources

- Prescribing Information

### Related treatment guides

- Polycythemia Vera

## Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer