Ofatumumab

Ofatumumab is a prescription medication used to treat chronic lymphocytic leukemia (CLL). 

• Ofatumumab is available under various brand names: Arzerra

Common side effects of Ofatumumab include:

• fever, cough, and flu symptoms.
• cold symptoms such as stuffy nose, sneezing, and sore throat.
• trouble breathing.
• diarrhea, nausea.
• mild rash; or
• tired feeling.

Serious side effects of Ofatumumab include:

• hives. 
• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• feel dizzy, nauseated, light-headed, confused, itchy, tingly, or have chest pain, jaw or arm pain, back pain, stomach pain, wheezing, chest tightness, or trouble breathing.
• serious brain infection: change in your mental state, decreased vision, weakness on one side of the body, or problems with speech or walking. 
• fever, chills, cough with yellow or green mucus.
• stabbing chest pain, wheezing, feeling short of breath.
• liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
• low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed; or
• signs of tumor cell breakdown--lower back pain, blood in the urine, little or no urination; numbness or tingly feeling around the mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.

Rare side effects of Ofatumumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 100 mg/5 mL vial
• 1000 mg/50 mL vial

Chronic lymphocytic leukemia (CLL), previously untreated: 

Adult dosage

Arzerra: IV: 

• Cycle 1 (the cycle is 28 days): 300 mg on day 1, followed by 1,000 mg on day 8; Subsequent cycles: 1,000 mg on day 1 every 28 days; continue for at least 3 cycles until best response or a maximum of 12 cycles 

CLL, relapsed: 

Adult dosage

Arzerra: IV: 

• Cycle 1 (a cycle is 28 days): 300 mg on day 1, followed by 1,000 mg on day 8; Subsequent cycles: 1,000 mg on day 1 every 28 days; continue for a maximum of 6 cycles (in combination with fludarabine and cyclophosphamide) 

CLL, refractory: 

Arzerra: IV: Initial dose:

•  300 mg on day 1, followed 1 week later by 2,000 mg once weekly for 7 doses (doses 2 to 8), followed 4 weeks later by 2,000 mg once every 4 weeks for 4 doses (doses 9 to 12; for a total of 12 doses)

CLL, extended treatment: 

Arzerra: IV: 

• 300 mg on day 1, followed by 1,000 mg on day 8, followed by 1,000 mg 7 weeks later, and then every 8 weeks for up to a maximum of 2 years

Multiple sclerosis, relapsing:

• SUB Q: Initial: 20 mg once weekly for 3 doses (weeks 0, 1, and 2); maintenance: 20 mg once monthly starting at week 4.
• Missed dose: Administer as soon as possible without waiting until the next scheduled dose; administer subsequent doses at the recommended intervals.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ofatumumab has no noted severe interactions with any other drugs.
• Ofatumumab has no noted serious interactions with any other drugs.
• Ofatumumab has  moderate interactions with any other drugs.
• Ofatumumab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to Ofatumumab

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ofatumumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ofatumumab?”

Cautions

• Ofatumumab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.
• If you have certain risk factors for hepatitis B, ofatumumab can cause this condition to come back or get worse, which could lead to liver failure or death. You will need frequent blood tests to check your liver function.
• Ofatumumab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking.
• If you have certain risk factors for hepatitis B, the virus could become active again while you are using ofatumumab and for up to several months after you stop using it. This has resulted in liver failure or death in some people using ofatumumab. Your doctor will perform blood tests to make sure you do not have conditions that may cause you to develop hepatitis B.
• Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
• Do not receive a "live" vaccine while using ofatumumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Pregnancy and Lactation

• Using ofatumumab during pregnancy could affect the immune system of the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this Ofatumumab.
• Lactation
  • It is not known whether ofatumumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.