
Fulphila
Fulphila (pegfilgrastim or pegfilgrastim-jmdb) is a biosimilar to Neulasta (pegfilgrastim). It's an injection used to lower the risk of infection from low white blood cell levels caused by certain cancer treatments. The medication is injected under the skin once per chemotherapy cycle, either at home or by a healthcare professional. Common side effects include bone pain and pain in the arms or legs.
What is Fulphila (pegfilgrastim)?
What is Fulphila (pegfilgrastim) used for?
- Lower the risk of infection in adults and children receiving certain cancer treatments that can lower white blood cell levels (febrile neutropenia)
How Fulphila (pegfilgrastim) works
Fulphila (pegfilgrastim) is a granulocyte colony-stimulating factor (G-CSF), a type of leukocyte growth factor. It works like G-CSF, a protein your body naturally makes. G-CSF triggers your bone marrow to make more neutrophils, a type of white blood cell that helps fight infections.
Drug facts
| Common Brands | Fulphila |
|---|---|
| Drug Class | Colony-stimulating factor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
More on Fulphila (pegfilgrastim) essentials
Side effects of Fulphila (pegfilgrastim)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Bone pain (31%)
- Pain in arms or legs (9%)
Less Common Side Effects
- Injection site reactions
- Rash
- Hives
Fulphila (pegfilgrastim) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Spleen rupture: pain in your left upper stomach, pain in your left shoulder
- Lung problem: shortness of breath, fever, trouble breathing, fast rate of breathing
- Serious allergic reaction: rash, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, sweating
- Kidney problems: swelling of your face or ankles, urinating less than usual, blood in your urine or dark colored urine
- Capillary leak syndrome: swelling of your stomach, dizziness or feeling faint, trouble breathing, urinating less than usual, tiredness
- Blood vessel inflammation: fever, stomach pain, back pain, headache, neck pain, generally feeling unwell
The following Fulphila (pegfilgrastim) side effects have also been reported
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:
Incidence not known
Black, tarry stools
bleeding gums
bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
blisters in the skin
blood in the urine or stools
cloudy urine
decrease in how much or how often you urinate
difficulty with swallowing
dizziness
fainting or lightheadedness
fast heartbeat
flushing or redness of the skin
hives or welts, skin rash
itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lower back or side pain
painful or difficult urination
pinpoint red spots on the skin
sores on the skin
stomach pain
swelling of the hands, ankles, feet, or lower legs
swollen glands
unusual bleeding or bruising
unusual tiredness or weakness
unusually warm skin
Get emergency help immediately if any of the following symptoms of overdose occur:
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
Belching
change in sense of taste
cracked lips
hair loss or thinning of the hair
indigestion
joint pain
lack or loss of strength
loss of appetite
muscle soreness
swelling or inflammation of the mouth
trouble sleeping
vomiting
weakness, generalized
Incidence not known
Body produces substance that can bind to drug making it less effective or cause side effects
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.
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Pros and cons of Fulphila (pegfilgrastim)
Pros
- Long-lasting and only needs to be given once per chemotherapy cycle
- Approved for adults and children
- Prefilled syringe cap isn't made with natural rubber latex
Cons
- Commonly causes bone pain and back pain
- Requires frequent lab work
- Must be timed carefully around chemotherapy
Pharmacist tips for Fulphila (pegfilgrastim)
- Fulphila (pegfilgrastim) shouldn't be given within 14 days before or 24 hours after chemotherapy. Getting the medication too close to chemotherapy can affect how well treatment works.
- Keep all blood test appointments while receiving Fulphila (pegfilgrastim). Your care team will check your white blood cell levels to make sure they're in a safe range.
- Bone pain is common with Fulphila (pegfilgrastim). Ask your care team which pain relievers are safe for you before taking anything on your own.
- Contact your care team right away if you have pain in the upper left side of your stomach or left shoulder while receiving Fulphila (pegfilgrastim). This could be a sign of a serious spleen problem.
- Pregnancy and breastfeeding: Talk to your care team before receiving Fulphila (pegfilgrastim) if you're pregnant, planning to become pregnant, or breastfeeding. There isn't enough information to know for sure whether the medication can harm an unborn or breastfed baby.
- Storage: Keep Fulphila (pegfilgrastim) in the refrigerator and protect it from light. Don't freeze or shake the medication.
How to use Fulphila (pegfilgrastim)
- If injecting at home, your care team will show you or your caregiver how to give the shot safely. Follow the Instructions for Use and ask your care team if you have questions.
- Take the syringe out of the refrigerator at least 30 minutes before your injection and let it reach room temperature. Throw away the syringe if it's been at room temperature for more than 72 hours.
- You can inject under the skin of your thigh or stomach, at least 2 inches away from your belly button. A caregiver can also give the shot in your upper outer buttocks or the outer area of your upper arm.
- To inject, pull the needle cap straight off. Then pinch a fold of clean skin. Insert the needle at a 45° to 90° angle, push the plunger all the way down, then remove the needle and release the plunger so the safety guard covers the needle.
- After each use, throw away the syringe in a sharps container. This helps prevent needlestick injuries to yourself or others.
Risks and warnings for Fulphila (pegfilgrastim)
Fulphila (pegfilgrastim) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Spleen rupture
Rarely, Fulphila (pegfilgrastim) can cause your spleen to become enlarged. In serious cases, the spleen can rupture (break open), which can be life-threatening. Get medical help right away if you have pain in the upper left side of your stomach or in your left shoulder.
Lung problem
Fulphila (pegfilgrastim) can cause acute respiratory distress syndrome (ARDS), a serious lung condition that makes it hard to breathe and get enough oxygen. Get medical help right away if you develop trouble breathing or shortness of breath, especially if you also have a fever.
Serious allergic reactions
- Risk factors: Allergy to Fulphila (pegfilgrastim) or similar medications
Fulphila (pegfilgrastim) can cause serious allergic reactions that can be life-threatening if not treated. These reactions are more likely after your first dose, but symptoms can return days after the first reaction is treated.
You shouldn't receive Fulphila (pegfilgrastim) if you've had a serious allergic reaction to it or a similar medication, such as Neupogen (filgrastim). Get medical help right away if you have trouble breathing, swelling of your face or throat, hives, or severe dizziness.
Sickle cell crisis in people with sickle cell anemia
- Risk factors: Sickle cell anemia
In people with sickle cell anemia, Fulphila (pegfilgrastim) can trigger a serious and sometimes life-threatening sickle cell crisis. Symptoms can include severe pain, trouble breathing, chest pain, fever, or extreme tiredness. If a sickle cell crisis happens, the care team will stop the medication and provide treatment.
Kidney problems
Fulphila (pegfilgrastim) can rarely cause glomerulonephritis, a condition where the tiny filters in the kidneys become inflamed. Signs can include blood in the urine, dark colored urine, swelling, or urinating less than usual. If this happens, the care team might lower the dose or stop the medication.
Changes in blood cell counts
Fulphila (pegfilgrastim) can cause your white blood cell count to become too high. Your care team will check your complete blood count (CBC) during treatment to make sure your levels stay in a safe range.
Fulphila (pegfilgrastim) can also lower your platelet count, which can raise your risk of bruising or bleeding. Tell your care team if you notice unusual bruising, nosebleeds, or bleeding that's hard to stop.
Capillary leak syndrome
Colony-stimulating factor medications like Fulphila (pegfilgrastim) can rarely cause capillary leak syndrome (CLS). This is a serious condition where fluid leaks out of small blood vessels into nearby tissues. It can cause low blood pressure, swelling, dizziness, or weakness and can be life-threatening without quick treatment. Get medical help right away if these symptoms develop.
Risk of certain cancers
Fulphila (pegfilgrastim) is a growth factor that mainly helps your body make more white blood cells. But there's a possibility it could also promote the growth of certain cancer cells.
Rarely, people with breast or lung cancer have developed blood cancers or bone marrow problems while receiving Fulphila (pegfilgrastim) with chemotherapy or radiation. Your care team will monitor your blood tests and might stop the medication if the risks become greater than the benefits.
Blood vessel inflammation
Fulphila (pegfilgrastim) can rarely cause serious inflammation of large or medium-sized blood vessels. This can happen as early as the first week of treatment. Contact your oncology care team right away if you develop an unexplained fever, stomach or back pain, headache, neck pain, or feel unusually unwell.
Fulphila (pegfilgrastim) dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 6mg/0.6ml | 1 syringe | $1,924.31 | $1,924.31 |
Typical dosage for Fulphila (pegfilgrastim)
Fulphila (pegfilgrastim) is given as an injection under the skin. It shouldn't be given within 14 days before or 24 hours after chemotherapy.
- Adults and children weighing 45 kg (99 lbs) or more: The typical dose is 6 mg once per chemotherapy cycle.
Interactions between Fulphila (pegfilgrastim) and other drugs
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.
How much does Fulphila (pegfilgrastim) cost?
$1,924.31
Fulphila (pegfilgrastim) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Fulphila (pegfilgrastim) will not be safe for you to take.
- Allergy to pegfilgrastim medications
- Allergy to filgrastim medications (e.g. Neupogen (filgrastim))
What are alternatives to Fulphila (pegfilgrastim)?
Prevention of low neutrophil-related complications in:
Preparation for blood collection for your own stem cell transplant (Neupogen, Nivestym, and Zarxio only)
Increase survival in people exposed to bone marrow-suppressing radiation (Neupogen only)
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