Anifrolumab

Anifrolumab is a prescription medication used for the treatment of moderate-to-severe systemic lupus erythematosus (SLE).

• Anifrolumab is available under the following different brand names: Saphnelo, anifrolumab-fnia

Common side effects of Anifrolumab include:

• headache,
• nausea,
• vomiting,
• dizziness, and
• tiredness

Serious side effects of Anifrolumab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe dizziness,
• sore throat,
• fever,
• chills,
• cough,
• shortness of breath,
• pain, numbness or tingling of the skin, and
• blistering skin

Rare side effects of Anifrolumab 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 include 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

• 300 mg/2 mL (single-dose vial)

Systemic Lupus Erythematosus

Adult dosage

• 300 mg IV every 4 weeks

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.

• Anifrolumab has severe interactions with no other drugs.
• Anifrolumab has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • BCG vaccine live
  • cholera vaccine
  • dengue vaccine
  • Ebola Zaire vaccine
  • influenza virus vaccine quadrivalent, intranasal
  • measles (rubeola) vaccine
  • measles mumps and rubella vaccine, live
  • measles, mumps, rubella and varicella vaccine, live
  • poliovirus vaccine live oral trivalent
  • rotavirus oral vaccine, live
  • rubella vaccine
  • smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating
  • smallpox (vaccinia) vaccine, attenuated
  • smallpox (vaccinia) vaccine, live
  • typhoid polysaccharide vaccine
  • typhoid vaccine live
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Anifrolumab has moderate interactions with the following drug:
  • ublituximab
• Anifrolumab has minor interactions with no 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 healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• History of anaphylaxis associated with anifrolumab

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Update immunizations, according to current immunization guidelines, before initiating therapy
• Serious infections
  • Serious and sometimes fatal infectious occurred
  • May increase the risk of respiratory tract infections and herpes zoster
  • Avoid initiating active infection until the infection resolves or is adequately treated
  • If signs or systems of infection occur, instruct patients to seek medical advice
  • Consider the benefit-risk if using in patients with severe or chronic infections
  • If an infection develops, or is not responding to standard anti-infective therapy, closely monitor the patient and consider interrupting therapy until the infection resolves
• Hypersensitivity reactions
  • Hypersensitivity reactions, including anaphylaxis and angioedema, reported
  • Other hypersensitivity reactions and infusion-related reactions occurred following the administration
  • Consider premedication before infusion for patients with a history of these reactions
  • Prepare to manage hypersensitivity reactions and infusion-related reactions
  • If such reactions occur, immediately interrupt administration and initiate appropriate therapy
• Malignancy
  • Use of immunosuppressants may increase the risk of malignancies
  • Unknown if anifrolumab may also increase such risk
  • Consider the benefit-risk in patients with known risk factors for developing or recurring malignancies before prescribing therapy
  • In patients who develop malignancies, consider the benefit-risk of continued treatment
• Other biologic therapies
  • Not recommended
  • Not studied in combination with other biologic therapies, including B-cell–targeted therapies
• Drug interaction overview
  • Live or live attenuated immunizations
    • Avoid use
  • Update immunizations, according to current immunization guidelines, before initiating

Pregnancy and Lactation

• Limited human data with use in pregnant females are insufficient to inform on drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome
• Pregnancy exposure registry
  • Monitor pregnancy outcomes in females exposed to anifrolumab during pregnancy
  • For more information, contact AstraZeneca at 1-877-693- 9268
• Clinical considerations
  • Monoclonal antibodies are known to cross the placenta as pregnancy progresses; therefore, anifrolumab exposure to the fetus may be greater during the third trimester of pregnancy
  • Pregnant females with SLE are at increased risk of adverse pregnancy outcomes (eg, worsening of underlying disease, premature birth, miscarriage, intrauterine growth restriction)
  • Maternal lupus nephritis may increase the risk of hypertension and preeclampsia/eclampsia
  • Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus a congenital heart block
• Lactation
  • No data are available regarding the presence of drug in human milk, its effects on breastfed children, or its effects on milk production
  • Detected in the milk of treated female cynomolgus monkeys
  • Maternal IgG is known to be present in human milk
  • If the drug is transferred into human milk, the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to therapy are unknown
  • Consider the benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child from therapy or from an underlying maternal condition