Description
Pivekimab sunirine-pvzy injection is used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN).
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of pivekimab sunirine-pvzy 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 pivekimab sunirine-pvzy injection in the elderly.
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.
Drug Interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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:
- Asthma or
- Sulfite allergy—Use with caution. This medicine contains sodium metabisulfite, which may cause serious allergic reactions.
- Edema (swelling)—Use with caution. May make this condition worse.
- Kidney disease, moderate to severe or
- Liver disease, moderate to severe—Use is not recommended in patients with these conditions.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 15 to 30 minutes every 3 weeks (21-day cycle).
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your doctor may also want you to stay for at least 4 hours to check for unwanted effects.
Your doctor may also give you other medicines (eg, allergy medicine, fever medicine, steroid) a day before or 30 to 60 minutes before infusion to help prevent infusion-related reactions.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed before and during treatment with this medicine to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start receiving this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for 7 months after your last dose. Males with female partners who can become pregnant must use effective birth control during treatment and for 4 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
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 (eg, hepatic veno-occlusive disease).
This medicine may cause infusion-related reactions, which can be life-threatening and require immediate reaction. Check with your doctor right away if you have back pain, blurred vision, chest discomfort or tightness, chills, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fever, feeling of warmth, redness of the face, neck, arms and occasionally, upper chest, headache, nausea and vomiting, sweating, trouble breathing, or unusual tiredness or weakness.
This medicine may cause edema (swelling) and fluid retention (too much water in the body). Check with your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet, decrease in amount of urine, noisy, rattling, or trouble breathing, rapid weight gain, swelling of the face, hands, feet, or lower legs, tingling of the hands or feet, or weight gain.
This medicine contains sodium metabisulfite, which may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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
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 or nurse immediately if any of the following side effects occur:
More common
- Agitation
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blue lips and fingernails
- blurred vision
- burning, itching, and pain in hairy areas, pus at the root of the hair
- burning, numbness, tingling, or painful sensations
- burning or stinging of the skin
- chest pain, discomfort, or tightness
- cloudy urine
- cold flu-like symptoms
- coma
- confusion
- cough
- coughing that sometimes produces a pink frothy sputum
- coughing up blood
- decrease or increase in amount of urine
- depression
- diarrhea
- difficult, fast, noisy breathing
- difficulty swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting or lightheadedness
- fast or slow heartbeat
- fever or chills
- general feeling of discomfort or illness
- headache
- hostility
- increased menstrual flow or vaginal bleeding
- increased sweating
- irritability
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- lethargy
- loss of taste or smell
- lower back or side pain
- muscle or body aches
- muscle twitching
- nausea or vomiting
- nosebleeds
- painful cold sores or blisters on lips, nose, eyes, or sex organs
- painful or difficult urination
- pale skin
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- seizures
- sneezing
- sore throat
- stomach pain
- stuffy or runny nose
- stupor
- sweating
- swelling in the legs and ankles
- swelling of the lower legs or arms
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
- thickening of bronchial secretions
- tingling of hands or feet
- trouble breathing
- ulcers, sores, or white spots in mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- weakness in the arms, hands, legs, or feet
Less common
- Bloated stomach
- pain and fullness in the right upper abdomen or stomach
- yellow eyes and skin
Incidence not known
- Hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
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
- Bone pain
- constipation
- decreased appetite
- swelling or inflammation of the mouth
- trouble sleeping
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.
DRG-80011879
