Ropeginterferon alfa-2b-njft (Subcutaneous)

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

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

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

If you are a woman who can get pregnant, your doctor may perform tests to confirm that you are not pregnant before starting this medicine. Using this medicine while pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment with this medicine and for at least 8 weeks after the last dose. If you think you may have become pregnant while using this medicine, tell your doctor immediately.

This medicine may cause some people to feel anxious, irritable, or show other unusual behaviors. It may also lead some individuals to have suicidal thoughts and tendencies or to feel more depressed. If you or your caregiver notice any of these side effects, inform your doctor right away.

Contact your doctor immediately if you experience blurred vision, chest pain, confusion, lightheadedness, dizziness, or fainting, a fast or irregular heartbeat, sudden fainting, trouble breathing, or unusual tiredness or weakness. These may be signs of serious heart problems.

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

• If possible, avoid people with infections. Contact your doctor immediately if you think you are getting an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Inform your doctor right away if you notice any unusual bleeding or bruising, black or tarry stools, blood in your urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Consult your 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 cautious when using sharp objects, like a safety razor or nail clippers, to avoid cuts.
• Avoid contact sports or other activities where bruising or injury could happen.

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

Pancreatitis (swelling of the pancreas) may develop while using this medicine. Contact your doctor immediately if you have bloating, sudden and severe stomach pain, chills, constipation, nausea, pain in your stomach, side, or abdomen, possibly radiating to your back, vomiting, fever, lightheadedness, or yellowing of your eyes or skin.

This medicine may cause diarrhea, which can sometimes be severe. It may occur 12 weeks or more after you start using this medicine. Do not take any medicine for diarrhea without first checking with your doctor. Diarrhea medicines may worsen the diarrhea or prolong it. If you have any questions about this or if mild diarrhea continues or gets worse, consult your doctor.

Notify your doctor immediately if you have a cough, trouble breathing, chest tightness, or any breathing problems while using this medicine. These could be signs of a serious lung issue.

Contact your doctor right away if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want your eyes to be examined by an ophthalmologist (eye doctor).

This medicine may increase cholesterol and fats in your blood. If this occurs, your doctor may prescribe medications to lower your cholesterol and fat levels.

Check with your doctor immediately if you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of your eyes or skin. These could be signs of a serious liver problem.

This medicine may cause tooth and gum problems, which could lead to tooth loss. It may also cause dry mouth, which can result in teeth or mouth issues if you take this medicine for a long time. Brush your teeth well (2 times a day) and visit your dentist regularly during treatment with this medicine.

Contact your doctor right away if you notice bloody urine, a decrease in urine frequency or amount, increased 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 signs of a serious kidney problem.

Serious skin reactions can occur with this medicine. Inform your doctor immediately if you experience blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while using this medicine.

This medicine may cause dizziness, drowsiness, or hallucinations. Do not drive or engage in any activities that could be dangerous until you know how this medicine affects you.

This medicine may impact your menstrual cycles. Discuss any concerns you have with your doctor.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must weigh the risks of taking it against the benefits it will provide. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Appropriate studies have not been done on how age affects the use of ropeginterferon alfa-2b-njft injection in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown specific problems in older adults that would limit the usefulness of ropeginterferon alfa-2b-njft injection. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require careful monitoring and possible dose adjustments.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the possible benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are important but not an exhaustive list.

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

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

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

• Heart or blood vessel disease (e.g., congestive heart failure, heart attack, stroke), severe or
• Severe heart rhythm problems or
• Uncontrolled hypertension or
• Moderate to severe liver disease or
• Mental health problems (e.g., depression, thoughts of suicide) or
• Patients who have had a transplant and take medicines that weaken the immune system or
• Serious or untreated autoimmune disorders, either active or historical—Should not be used in patients with these conditions.

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

Along with its necessary effects, a medicine can cause some unwanted effects. Not all side effects may occur, but if they do, they may require medical attention.

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

More common

• Black, tarry stools
• Bladder pain
• Bleeding gums
• 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. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• BESREMi

Available Dosage Forms:

• Solution

Pharmacologic Class: Ropeginterferon Alfa-2b

Find detailed information on biosimilars for this medication.

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.