satralizumab (Rx)

Brand and Other Names:Enspryng, satralizumab-mwge
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for SC injection

  • 120mg/mL single-dose prefilled syringe

Neuromyelitis Optica Spectrum Disorder

Indicated for neuromyelitis optica spectrum disorder (NMOSD) in adults who are antiaquaporin-4 (AQP4) antibody positive

Loading: 120 mg SC at Weeks 0, 2, and 4

Maintenance: 120 mg SC q4Weeks

Dosage Modifications

Renal impairment

  • No formal pharmacokinetic studies conducted

Hepatic impairment

  • No formal pharmacokinetic studies conducted
  • Caution when initiating if AST/ALT levels >1.5x ULN

ALT/AST >5x ULN during therapy

  • If associated with any bilirubin elevation, discontinue and do not reinitiate
  • If not associated with any bilirubin elevation above ULN, discontinue and reinitiate when ALT or AST returned to normal range following benefit-risk assessment
  • Restart after liver transaminase elevation
    • <12 weeks: 120 mg SC q4Weeks
    • ≥12 weeks: 120 mg SC q4Weeks at Weeks 0, 2, and 4, followed by 120 mg q4Weeks; Week 0 refers to first administration after missed dose
    • If treatment restarted, closely monitor liver parameters; discontinue if any subsequent increased ALT/AST and/or bilirubin above the ULN observed and do not reinitiate

Neutrophil count

  • <1 x 109/L: Interrupt dosing until >1 x 109/L

Dosing Considerations

Before every dose: Assess for active infection, including localized infections; in case of active infection, delay use until the infection is resolved

Before initiating

  • Evaluate for active tuberculosis (TB) and test for latent TB infection; consult infectious disease expert if positive
  • Perform hepatitis B virus (HBV) screening; consult liver disease expert for patients who are negative for HBsAg and positive for HB core antibody (HBcAb+) or are HBV carriers (HBsAg+)
  • Complete scheduled vaccinations

Liver transaminases

  • Before initiating: Assess liver transaminases and serum bilirubin; caution if AST/ALT levels >1.5x ULN
  • During treatment: Measure ALT/AST q4Weeks x 3 months, then q3Months x 1 year, and thereafter as clinically needed

Neutrophil counts

  • Monitor neutrophils 4-8 weeks after initiation and thereafter at regular clinically determined intervals

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and satralizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (21)

              • adenovirus types 4 and 7 live, oral

                satralizumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • BCG vaccine live

                satralizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • cholera vaccine

                satralizumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • dengue vaccine

                satralizumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • Ebola Zaire vaccine

                satralizumab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • influenza virus vaccine quadrivalent, intranasal

                satralizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • measles (rubeola) vaccine

                satralizumab decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • measles mumps and rubella vaccine, live

                satralizumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • measles, mumps, rubella and varicella vaccine, live

                satralizumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • poliovirus vaccine live oral trivalent

                satralizumab decreases effects of poliovirus vaccine live oral trivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • rotavirus oral vaccine, live

                satralizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • rubella vaccine

                satralizumab decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating

                satralizumab decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • smallpox (vaccinia) vaccine, attenuated

                satralizumab decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • smallpox (vaccinia) vaccine, live

                satralizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • typhoid polysaccharide vaccine

                satralizumab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • typhoid vaccine live

                satralizumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • upadacitinib

                satralizumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.

              • varicella virus vaccine live

                satralizumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • yellow fever vaccine

                satralizumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • zoster vaccine live

                satralizumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              Monitor Closely (41)

              • anthrax vaccine adsorbed

                satralizumab decreases effects of anthrax vaccine adsorbed by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • anthrax vaccine adsorbed, adjuvanted

                satralizumab decreases effects of anthrax vaccine adsorbed, adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • COVID-19 vaccine, adjuvanted-Novavax

                satralizumab decreases effects of COVID-19 vaccine, adjuvanted-Novavax by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • COVID-19 vaccine, mRNA-Moderna

                satralizumab decreases effects of COVID-19 vaccine, mRNA-Moderna by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • COVID-19 vaccine, mRNA-Pfizer

                satralizumab decreases effects of COVID-19 vaccine, mRNA-Pfizer by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • COVID-19 vaccine, viral vector-Janssen

                satralizumab decreases effects of COVID-19 vaccine, viral vector-Janssen by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • haemophilus influenzae type b vaccine

                satralizumab decreases effects of haemophilus influenzae type b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • hepatitis A vaccine inactivated

                satralizumab decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • hepatitis a/b vaccine

                satralizumab decreases effects of hepatitis a/b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • hepatitis b vaccine

                satralizumab decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • HIV vaccine

                satralizumab decreases effects of HIV vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • human papillomavirus vaccine, bivalent

                satralizumab decreases effects of human papillomavirus vaccine, bivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • human papillomavirus vaccine, nonavalent

                satralizumab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • human papillomavirus vaccine, quadrivalent

                satralizumab decreases effects of human papillomavirus vaccine, quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • influenza A (H5N1) vaccine

                satralizumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • influenza virus vaccine (H5N1), adjuvanted

                satralizumab decreases effects of influenza virus vaccine (H5N1), adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • influenza virus vaccine quadrivalent

                satralizumab decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • influenza virus vaccine quadrivalent, adjuvanted

                satralizumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • influenza virus vaccine quadrivalent, cell-cultured

                satralizumab decreases effects of influenza virus vaccine quadrivalent, cell-cultured by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • influenza virus vaccine quadrivalent, recombinant

                satralizumab decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • influenza virus vaccine trivalent

                satralizumab decreases effects of influenza virus vaccine trivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • influenza virus vaccine trivalent, adjuvanted

                satralizumab decreases effects of influenza virus vaccine trivalent, adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • influenza virus vaccine trivalent, recombinant

                satralizumab decreases effects of influenza virus vaccine trivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • Japanese encephalitis virus vaccine

                satralizumab decreases effects of Japanese encephalitis virus vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine

                satralizumab decreases effects of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • meningococcal A C Y and W-135 diphtheria conjugate vaccine

                satralizumab decreases effects of meningococcal A C Y and W-135 diphtheria conjugate vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • meningococcal A C Y and W-135 polysaccharide vaccine combined

                satralizumab decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • meningococcal C and Y/haemophilus influenza type B vaccine

                satralizumab decreases effects of meningococcal C and Y/haemophilus influenza type B vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • meningococcal group B vaccine

                satralizumab decreases effects of meningococcal group B vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • pneumococcal vaccine 13-valent

                satralizumab decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • pneumococcal vaccine 15-valent

                satralizumab decreases effects of pneumococcal vaccine 15-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • pneumococcal vaccine 20-valent

                satralizumab decreases effects of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • pneumococcal vaccine heptavalent

                satralizumab decreases effects of pneumococcal vaccine heptavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • pneumococcal vaccine polyvalent

                satralizumab decreases effects of pneumococcal vaccine polyvalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • poliovirus vaccine inactivated

                satralizumab decreases effects of poliovirus vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • rabies vaccine

                satralizumab decreases effects of rabies vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • rabies vaccine chick embryo cell derived

                satralizumab decreases effects of rabies vaccine chick embryo cell derived by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • SARS-CoV-2 vaccine, inactivated

                satralizumab decreases effects of SARS-CoV-2 vaccine, inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • tetanus toxoid adsorbed or fluid

                satralizumab decreases effects of tetanus toxoid adsorbed or fluid by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • tick-borne encephalitis vaccine

                satralizumab decreases effects of tick-borne encephalitis vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              • zoster vaccine recombinant

                satralizumab decreases effects of zoster vaccine recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .

              Minor (0)

                Previous
                Next:

                Adverse Effects

                >10%

                ALT >ULN (43%)

                Platelets

                Nasopharyngitis (31%)

                Headache (27%)

                Triglycerides >300 mg/dL (12-17%)

                AST >ULN (25%)

                Upper respiratory tract infection (19%)

                Rash (17%)

                Arthralgia (12-17%)

                Pain in extremity (15%)

                Fatigue (15%)

                Nausea (15%)

                Gastritis (15%)

                Neutrophils <1 x 109/L (10-15%)

                Nasopharyngitis (12%)

                1-10%

                Pruritus (10%)

                Depression (10%)

                Cellulitis (10%)

                Neutropenia (10%)

                Blood CPK increased (10%)

                Fall (10%)

                ALT/AST 3x ULN (3%)

                Previous
                Next:

                Warnings

                Contraindications

                Hypersensitivity

                Active hepatitis B infection

                Active or untreated latent TB

                Cautions

                Hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other interleukin 6 (IL-6) antagonists

                Increased risk of infections, including serious and potentially fatal infections, observed with IL-6 antagonists, including satralizumab; risk of hepatitis B virus reactivation or TB infection

                Mild and moderate liver enzyme elevations observed; monitor before and during treatment

                Regularly monitor neutrophil count during treatment

                Drug interaction overview

                • Vaccines
                  • Vaccination with live-attenuated or live vaccines not recommended during treatment
                  • Administer all vaccines according to immunization guidelines at least 4 weeks before initiating satralizumab when possible (or at least 2 weeks before initiation of nonlive vaccines)
                • CYP450 substrates
                  • Clinical significance unknown
                  • IL-6 signaling suppression is expected to have minor impact on exposure of concomitant medications metabolized by CYP450 enzymes
                Previous
                Next:

                Pregnancy & Lactation

                Pregnancy

                Data are not available regarding developmental risk associated with the use in pregnant females

                Clinical considerations

                • Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester
                • Consider risks and benefits before administering live or live-attenuated vaccines to infants exposed to satralizumab in utero

                Animal studies

                • No adverse effects on maternal animals or fetal development observed in pregnant monkeys and their offspring, with satralizumab at doses up to 50 mg/kg/week

                Pregnancy exposure registry

                • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this drug during pregnancy
                • Healthcare providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-277-9338

                Lactation

                No information available on excretion in human milk, effects on breastfed infants, or effects on milk production

                Human IgG excreted in human milk; potential for absorption in infant is unknown

                Animal studies

                • Excreted in milk of lactating monkeys administered satralizumab throughout pregnancy

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

                Previous
                Next:

                Pharmacology

                Mechanism of Action

                Humanized monoclonal antibody that targets the interleukin 6 (IL-6) receptor

                Cytokine IL-6 is thought to be a key cause of NMOSD, triggering the inflammation cascade and leading to damage and disability

                Absorption

                Bioavailability: 85%

                Steady-state after 8-week loading dose

                • Peak plasma concentration: 31.5 mcg/mL
                • Minimum plasma concentration: 19.7 mcg/mL
                • AUC 737 mcgmL/day

                Distribution

                Vd

                • Biphasic distribution
                • Central volume: 3.46 L
                • Peripheral volume: 2.07 L
                • Intercompartmental clearance: 0.336 L/day

                Metabolism

                Not studied; antibodies cleared principally by catabolism

                Elimination

                Half-life: ~30 days

                Total clearance: 0.0601 L/day

                Excretion: Monoclonal antibodies are not eliminated via renal or hepatic pathways

                Previous
                Next:

                Administration

                SC Preparation

                Remove syringe from refrigerator and let sit at room temperature for 30 minutes

                Solution is colorless to slightly yellow

                Do not use if expiration date has passed, syringe is damaged, or liquid is cloudy

                SC Administration

                SC use only; intended for patient self-administration after proper training

                Inject full amount in syringe (ie, 120 mg/mL) SC in lower abdomen or front and middle of thighs; rotate injection sites

                Do not inject into the 2-inch are around naval; do not inject into moles, scars, or skin that is tender, bruised, red, hard, or not intact

                Delayed or missed doses

                • Recommendations for any reason other than increased liver enzymes
                • <8 weeks during maintenance or missed loading dose
                  • Administer 120 mg SC as soon as possible, and do not wait until the next planned dose
                  • Maintenance period: After delayed/missed dose administered, reset dose schedule to q4Weeks
                  • Second loading dose delayed/missed: Administer dose as soon as possible, then administer third (final) loading dose 2 weeks later
                  • Third loading dose delayed/missed: Administer dose as soon as possible, then first maintenance dose 4 weeks later
                • 8 to <12 weeks
                  • 120 mg SC at 0 and 2 weeks, followed by 120 mg q4Weeks
                • ≥12 weeks
                  • 120 mg SC at 0, 2, and 4 weeks followed by 120 mg q4Weeks

                Storage

                Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light

                If unopened before administration, can be removed from and returned to refrigerator, if necessary; do not exceed 8 days combined time out of refrigerator at room temperature <30ºC (86ºF)

                Do not freeze

                Do not shake

                Previous
                Next:

                Images

                No images available for this drug.
                Previous
                Next:

                Patient Handout

                A Patient Handout is not currently available for this monograph.
                Previous
                Next:

                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                Additional Offers
                Email to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Email Forms to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Previous
                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.