Saphnelo 300/2ml Sol Injection, 2ml
It is used to treat lupus.
Drug Class
Immunosuppressant
Pharmacologic Class
Type I Interferon Receptor Antagonist
Pregnancy Category
Not available
FDA Approved
Jul 2021
DEA Schedule
Not Controlled
Overview
What is this medicine?
Saphnelo is a medicine used to treat adults with moderate to severe systemic lupus erythematosus (SLE), also known as lupus. It works by blocking a protein in your body called Type I interferon, which is overactive in people with lupus and contributes to inflammation and disease activity.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It's essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time. In some cases, other medications may be given before this medication to help minimize side effects.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best way to store it.
What to Do If You Miss a Dose
If you miss a dose, contact your doctor to find out what steps to take next.
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It's essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time. In some cases, other medications may be given before this medication to help minimize side effects.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best way to store it.
What to Do If You Miss a Dose
If you miss a dose, contact your doctor to find out what steps to take next.
Lifestyle & Tips
- Avoid live or live-attenuated vaccines during treatment and for a period after treatment, as recommended by your doctor.
- Report any signs of infection (e.g., fever, chills, cough, sore throat) to your doctor immediately.
- Inform your healthcare provider about all medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements.
- Discuss any planned surgeries or dental procedures with your doctor.
- Limit sun exposure and use sun protection, as lupus can cause photosensitivity.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
300 mg administered by intravenous infusion over 30 minutes every 4 weeks
Dose Range:
300 - 300 mg
Condition-Specific Dosing:
Systemic Lupus Erythematosus (SLE):
300 mg administered by intravenous infusion over 30 minutes every 4 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
No specific recommendations; not expected to be removed by dialysis due to large molecular weight.
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Pharmacology
Mechanism of Action
Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the Type I interferon receptor (IFNAR1), thereby blocking the activity of Type I interferons (IFN-Ξ±, IFN-Ξ², IFN-ΞΊ, IFN-Ο). This inhibition prevents Type I IFN signaling, which is implicated in the pathogenesis of Systemic Lupus Erythematosus (SLE).
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
End of infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 6.2 L
ProteinBinding:
Not specifically applicable (monoclonal antibody, not binding to plasma proteins in a typical drug-protein binding manner)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 21 days
Clearance:
Approximately 0.19 L/day
ExcretionRoute:
Not applicable (degraded into peptides/amino acids)
Unchanged:
Not applicable (biologic, catabolized)
Pharmacodynamics
OnsetOfAction:
Not precisely defined for clinical effect, but pharmacodynamic markers (e.g., reduction in IFN gene signature) show changes within weeks.
PeakEffect:
Not precisely defined for clinical effect, but steady-state concentrations are reached by approximately 12 weeks.
DurationOfAction:
Related to half-life; effects persist for several weeks after last dose.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Warm, red, or painful skin or sores on the body
Stomach pain or diarrhea
Frequent urination
Muscle pain
Excessive sweating
Shingles
Dizziness or fainting
Headache
Upset stomach or vomiting
Feeling tired or weak
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
* Signs of a common cold
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Warm, red, or painful skin or sores on the body
Stomach pain or diarrhea
Frequent urination
Muscle pain
Excessive sweating
Shingles
Dizziness or fainting
Headache
Upset stomach or vomiting
Feeling tired or weak
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
* Signs of a common cold
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of infection: fever, chills, body aches, cough, sore throat, painful urination, skin sores.
- Allergic reactions: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing, dizziness.
- Headache (common, but report severe or persistent headaches).
- Herpes zoster (shingles) symptoms: painful rash, blisters.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney or nervous system problems caused by lupus.
If you have an active infection.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney or nervous system problems caused by lupus.
If you have an active infection.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be more susceptible to infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or the flu.
Before starting treatment with this medication, ensure you are up to date on all recommended vaccinations. However, consult with your doctor before receiving any vaccines, as some may not be effective or may increase the risk of infection when used in conjunction with this drug.
During the infusion of this medication, some individuals may experience side effects. If you encounter any adverse reactions during the infusion, promptly notify your doctor.
It is crucial to be aware that medications like this one, which suppress the immune system, may increase the risk of developing cancer. If you have concerns or questions, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
While taking this drug, you may be more susceptible to infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or the flu.
Before starting treatment with this medication, ensure you are up to date on all recommended vaccinations. However, consult with your doctor before receiving any vaccines, as some may not be effective or may increase the risk of infection when used in conjunction with this drug.
During the infusion of this medication, some individuals may experience side effects. If you encounter any adverse reactions during the infusion, promptly notify your doctor.
It is crucial to be aware that medications like this one, which suppress the immune system, may increase the risk of developing cancer. If you have concerns or questions, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 1000 mg have been administered without dose-limiting toxicity.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Contraindicated Interactions
- Live or live-attenuated vaccines (during and shortly after treatment)
Major Interactions
- Other biologics for SLE (e.g., belimumab) - concomitant use not recommended due to lack of data and potential for increased immunosuppression.
- Potent immunosuppressants (e.g., cyclophosphamide, rituximab) - concomitant use not recommended due to lack of data and potential for increased immunosuppression.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating immunosuppressive therapy.
Timing: Prior to initiation of therapy
Hepatitis B and C screening
Rationale: To assess for chronic viral infections that could reactivate with immunosuppression.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC)
Rationale: To establish baseline hematologic parameters.
Timing: Prior to initiation of therapy
Renal and Liver Function Tests
Rationale: To establish baseline organ function.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: Continuously
Target: Absence of fever, malaise, localized infection signs
Action Threshold: Any new or worsening signs/symptoms of infection; consider holding therapy and initiating appropriate treatment.
Signs and symptoms of hypersensitivity reactions
Frequency: During and after infusion
Target: Absence of rash, urticaria, dyspnea, hypotension, angioedema
Action Threshold: Any signs of hypersensitivity; stop infusion immediately and manage symptomatically.
Malignancy screening (skin checks, age-appropriate cancer screening)
Frequency: Periodically, as clinically indicated
Target: Absence of new or suspicious lesions/findings
Action Threshold: New or suspicious findings; refer for further evaluation.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Cough
- Fatigue
- Painful urination
- Skin rash
- Hives
- Swelling of face/lips/tongue/throat
- Difficulty breathing
- Dizziness
- Headache
- Nausea
- Diarrhea
- Abdominal pain
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Anifrolumab in pregnant women. Monoclonal antibodies, including Anifrolumab, are known to cross the placental barrier. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally, IgG transfer is lowest in the first trimester.
Second Trimester:
Increased IgG transfer across the placenta.
Third Trimester:
Highest IgG transfer across the placenta, potentially leading to fetal exposure and effects on the developing immune system.
Lactation
Human IgG is known to be excreted in breast milk. The effects of Anifrolumab on breastfed infants or milk production are unknown. Consider the developmental and health benefits of breastfeeding along with the motherβs clinical need for Anifrolumab and any potential adverse effects on the breastfed infant from Anifrolumab or from the underlying maternal condition.
Infant Risk:
L3 (Moderately safe) - While IgG is present in breast milk, it is largely degraded in the infant's gastrointestinal tract, and systemic absorption by the infant is likely low. However, potential effects on the infant's developing immune system cannot be excluded.
Pediatric Use
The safety and efficacy of Anifrolumab in pediatric patients (less than 18 years of age) have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (β₯65 years) and younger patients. No dose adjustment is required in elderly patients. However, caution should be exercised in elderly patients due to the generally higher incidence of infections and malignancies in this population.
Clinical Information
Clinical Pearls
- Anifrolumab is the first biologic specifically targeting Type I interferon pathway for SLE.
- It is indicated for moderate to severe active SLE in adults, as an add-on therapy to standard of care.
- Patients should be screened for tuberculosis and viral hepatitis prior to initiation.
- Risk of infection, particularly respiratory tract infections and herpes zoster (shingles), is increased. Vaccination against herpes zoster should be considered prior to treatment if appropriate.
- Hypersensitivity reactions, including anaphylaxis, can occur. Patients should be monitored during and after infusion.
- Concomitant use with other biologics for SLE or potent immunosuppressants (e.g., cyclophosphamide, rituximab) is not recommended due to insufficient data on safety and efficacy.
- Live or live-attenuated vaccines should not be administered concurrently with Anifrolumab.
Alternative Therapies
- Belimumab (Benlysta) - another biologic for SLE, targets B-lymphocyte stimulator (BLyS)
- Hydroxychloroquine (Plaquenil) - antimalarial, cornerstone of SLE treatment
- Corticosteroids (e.g., Prednisone) - for acute flares and disease control
- Immunosuppressants (e.g., Mycophenolate Mofetil, Azathioprine, Methotrexate) - for disease control and steroid-sparing effects
- Voclosporin (Lupkynis) - for lupus nephritis
Cost & Coverage
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.