Description
Ofatumumab injection is used in combination with chlorambucil to treat a type of cancer of the white blood cells called chronic lymphocytic leukemia (CLL) in patients who have not received any treatments in the past. It is also used in combination with fludarabine and cyclophosphamide to treat patients with relapsed CLL. This medicine is also used in patients with CLL who have already been treated with other medicines (eg, alemtuzumab, fludarabine) that did not work well.
Ofatumumab injection is also used to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease.
Ofatumumab interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by ofatumumab, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Some unwanted effects, such as a skin rash, may not be serious but may cause concern. Some of the unwanted effects do not occur until months or years after the medicine is used.
Before you begin treatment with ofatumumab, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.
Arzerra® is to be given only by or under the direct supervision of your doctor. Kesimpta® is available only with your doctor's prescription.
This product is available in the following dosage forms:
- 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 ofatumumab 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 ofatumumab injection in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, neutropenia, pneumonia) which may require caution.
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. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Varicella Virus Vaccine, Live
- Zoster Vaccine, Live
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.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Influenza Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Smallpox Monkeypox Vaccine, Live Non-Replicating
- Smallpox Vaccine
- Typhoid Vaccine, Live
- Yellow Fever Vaccine
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:
- Hepatitis B, active—Should not be used in patients with this condition.
- Hepatitis B, or history of—Use with caution. May make this condition worse.
- Infection (eg, bacteria, fungus, virus) or
- Weak immune system—May decrease your body's ability to fight infection.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins or as a shot under your skin, usually on the front of your thighs, stomach, or upper arms.
Arzerra® needs to be given slowly, so the IV will remain in place for at least an hour. You may also receive medicines to help prevent allergic reactions.
This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Kesimpta® may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.
To use the prefilled syringe or pen:
- Wash your hands with soap and water before and after using this medicine.
- Allow 15 to 30 minutes for the syringe to warm up to room temperature.
- Do not remove the needle cover on the prefilled syringe while allowing the medicine to reach to room temperature. Remove it before use.
- Check the liquid in the syringe or pen. It should be clear to slightly cloudy and colorless to slightly brownish-yellow. Do not use it if it is cloudy, discolored, or has particles in it.
- Do not shake. Do not use the prefilled syringe or pen if it has been damaged, broken, or if you dropped it with the cap removed.
- Do not inject into skin areas that are red, bruised, tender, hard, or scaly, or areas with scars or stretch marks.
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 (prefilled syringe or pen):
- For multiple sclerosis (MS):
- Adults—At first, 20 milligrams (mg) injected under the skin at Weeks 0, 1, and 2. Followed by 20 mg once a month starting at Week 4.
- Children—Use and dose must be determined by your doctor.
- For multiple sclerosis (MS):
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic 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.
Keep the medicine in its original carton to protect it from light. You may store this medicine at room temperature for up to 7 days. If stored at room temperature, you may return the unused medicine in the refrigerator and use it within 7 days. Throw away the medicine if not used within those 7 days.
Throw away used pens and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood and urine tests may be needed to check for unwanted effects.
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 and for at least 6 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause chest pain, fever, chills, itching, hives, flushing of the face, rash, dizziness, fainting, or lightheadedness, trouble breathing, or swelling of the face, tongue, and throat within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, 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, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.
This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
Ofatumumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting a serious infection (eg, bacterial, fungal, viral). It can also lower the number of platelets, which 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 increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
This medicine may cause hepatitis B virus reactivation. Check with your doctor right away if you have any symptoms of liver problems, including yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or severe tiredness.
Do not have any live vaccines (immunizations) while you are being treated with ofatumumab injection. You should have completed any needed immunizations at least 4 weeks for live or live-attenuated vaccines and at least 2 weeks for non-live (inactivated) vaccines before starting treatment with this medicine. Check with your doctor before having any vaccines.
Do not take other medicines unless thy 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
- Black, tarry stools
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- body aches or pain
- chest pain or tightness
- chills
- confusion
- cough producing mucus
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- ear congestion
- facial swelling
- fainting
- fast heartbeat
- feeling of warmth
- headache
- hives or welts, itching, or skin rash
- increased sweating
- lightheadedness
- loss of voice
- lower back or side pain
- nausea or vomiting
- painful blisters on the trunk of the body
- painful or difficult urination
- pale skin
- rapid, shallow breathing
- redness of the face, neck, arms, and occasionally, upper chest
- runny or stuffy nose
- sneezing
- sore throat
- tingling of the hands or feet
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Less common
- Fast, pounding, or irregular heartbeat or pulse
- nervousness
- pounding in the ears
- slow heartbeat
Incidence not known
- Blistering, peeling, or loosening of the skin
- dark urine
- diarrhea
- difficulty swallowing
- fluid-filled skin blisters
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- no blood pressure or pulse
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- sensitivity to the sun
- skin thinness
- stopping of heart
- unconsciousness
- yellow eyes or skin
Check with your doctor immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- chills
- cough
- difficult, burning, or painful urination
- dryness or soreness of throat
- ear congestion
- fever
- flushing, redness of skin
- frequent urge to urinate
- hoarseness
- joint pain
- loss of voice
- lower back or side pain
- muscle aches
- pain or tenderness around eyes and cheekbones
- pain, itching, swelling of the skin
- runny nose
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- swollen joints
- tender, swollen glands in the neck
- trouble in swallowing
- unusually warm skin
- voice changes
- vomiting
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
- Back pain
- muscle aches
- redness of the skin
- trouble sleeping
Less common
- 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
- muscle spasms
- pain or tenderness around the eyes and cheekbones
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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