Depemokimab
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Prepare this dose
Your numbers for depemokimab. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
Preparation and Administration Instructions for EXDENSUR
EXDENSUR is for subcutaneous use only.
EXDENSUR should be administered by a healthcare provider.
Do not use EXDENSUR prefilled syringe if the security seal on the carton has been broken or if it has been dropped or damaged. Preparation Instructions 1. Remove the prefilled syringe from the refrigerator. Holding the middle of the prefilled syringe, take it out from the tray and allow it to sit at room temperature for 30 minutes prior to injection.
Do not warm EXDENSUR injection in any other way. Do not remove the needle cap until you are ready to inject. Do not use the syringe if it has been left out of the carton for more than 8 hours. 2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
EXDENSUR should be colorless to yellow to brown, clear to opalescent in color. Do not use EXDENSUR if the product exhibits discoloration, cloudiness, or particulate matter. It is normal to see an air bubble. Do not expel the air bubble prior to administration. Do not shake the device. 3. Choose the injection site; administer EXDENSUR into upper arm, thigh, or abdomen, avoiding the 2 inches (5 cm) around the navel.
Do not give injections into areas where the skin is tender, bruised, red, or hard. Administration Instructions Figure 1. EXDENSUR Prefilled Syringe Components 1. Pull Off the Gray Needle Cap Remove the gray needle cap from the syringe by pulling it straight off, away from the needle. Do not handle the syringe by the white plunger while removing the gray needle cap.
Do not put the gray needle cap back onto the syringe. Inject within 5 minutes after removing the gray needle cap. 2. Position the Syringe at the Injection Site Use your free hand to gently pinch the skin around the cleaned injection site. Do not handle the syringe by the white plunger while inserting the needle into the pinched skin.
Hold the middle of the syringe and insert the entire needle into the pinched skin at a 45 degree angle, as shown. 3. Start the Injection and Fully Press the White Plunger Slowly push down on the white plunger with your thumb to inject the full dose. Make sure the white plunger is pushed all the way down until the stopper reaches the bottom of the syringe and all of the medication is injected. 4.
Slowly Lift Thumb After Injection Completes Slowly lift your thumb up. This will allow the white plunger to come up and the needle to automatically pull up (retract) into the needle guard. After removing the syringe from the injection site, release the pinched skin. 5. Throw Away Dispose of used syringe according to local health and safety laws.
Figure 1 1. Pull Off the Gray Needle Cap 2. Position the Syringe at the Injection Site 3. Start the Injection and Fully Press the White Plunger 4. Slowly Lift Thumb After Injection Completes
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for depemokimab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from clinical trials with EXDENSUR use in pregnant women are insufficient to identify a drug‑associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with asthma in pregnancy (see Clinical Considerations). Transport of endogenous immunoglobulin G (IgG) antibodies and monoclonal antibodies, such as depemokimab‑ulaa, across the placenta increases as pregnancy progresses and peaks during the third trimester.
The impact of the YTE modification on placental transfer is uncertain [see Clinical Pharmacology ( 12.1 )] ; however, the presence of the YTE modification may lead to prolonged and increased exposure of the infant exposed in utero , and the potential of clinical impact is unknown and should be considered. No treatment‑related effects on embryofetal or postnatal development have been shown in animal studies targeting interleukin‑5 (IL‑5) signaling pathways (see Data) . The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Pregnant women exposed to EXDENSUR, or their healthcare providers, should report EXDENSUR exposure by calling 1‑888‑825‑5249. Clinical Considerations Disease ‑ Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother, and prematurity, low birth weight, and small for gestational age in the neonate.
The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Animal Data: Reproductive toxicology studies have not been conducted with depemokimab‑ulaa. In animal studies targeting the IL‑5 signaling pathway with a related biologic product without the YTE modification, there were no developmental effects observed [see Nonclinical Toxicology ( 13 )] . Embryofetal development of IL‑5 deficient mice has been reported to be generally unaffected relative to wild‑type mice.
Breastfeeding (LactMed)
No information is available on the clinical use of daclizumab during breastfeeding. Because depemokimab is a large protein molecule with a molecular weight of about 149,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, depemokimab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.