Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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)
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%) Pruritus (10%) Depression (10%) Cellulitis (10%) Neutropenia (10%) Blood CPK increased (10%) Fall (10%) ALT/AST 3x ULN (3%)1-10%
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
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.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
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
Images
Formulary
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.
