Product information and disease description Product description Product information Dosing and administration

Administration

9 evidence topics · 3 sources

Route, supervised first dose, and self-administration

“HIBSAGO must be administered under the guidance and supervision of a healthcare provider for the initial dose to ensure proper injection technique.” (opens the prescribing information at this quote)
“Patients or caregivers may administer HIBSAGO after their healthcare provider determines that it is appropriate and with medical follow-up, including laboratory testing. Healthcare providers must provide proper training in subcutaneous injection technique before the patient or caregivers can administer HIBSAGO” (opens the prescribing information at this quote)

“Six-month treatment with option of self-administration after first dose” (opens the source at this quote in a new tab)

Prefilled syringe and needle

“Injection: 150 mg/mL of bepirovirsen as a clear, colorless to yellow sterile solution with no visible particulates in a single-dose prefilled glass syringe within a safety syringe device.” (opens the prescribing information at this quote)
“HIBSAGO injection is supplied as two, 1-mL, single-dose, prefilled syringes with a 0.5 inch (12.7 mm), 27-gauge, stainless steel needle assembled with a needle guard.” (opens the prescribing information at this quote)

Preparation before injection

“Ensure HIBSAGO has been at room temperature (below 86°F [30°C]) for a minimum of 30 minutes prior to injection” (opens the prescribing information at this quote)
“Prior to administration, visually inspect the window of the prefilled syringes for particulate matter or discoloration. HIBSAGO injection should be clear and colorless to yellow and free of visible particulate matter. Do not use HIBSAGO injection if the product exhibits discoloration, cloudiness, or particulate matter. Do not shake the HIBSAGO syringe. Do not use the syringes if they have been dropped or damaged.” (opens the prescribing information at this quote)

Injection sites, two-syringe dose, and site rotation

“Inject into the thigh or abdomen, avoiding the 2 inches (5 cm) around the navel. The outer area of the upper arm can also be used if a caregiver administers the subcutaneous injections.” (opens the prescribing information at this quote)
“For a 300 mg dose, administer 2 x 150 mg pre-filled syringes, inject one right after the other. Choose a different injection site for each injection, at least 2 inches (5 cm) from the other injection sites” (opens the prescribing information at this quote)
“For a 150 mg dose administer 1 x 150 mg pre-filled syringe injection.” (opens the prescribing information at this quote)
“Never give injections into areas where the skin is tender, bruised, red, or hard. Rotate injection sites to reduce the risk of injection site reactions” (opens the prescribing information at this quote)
“Ensure that injection sites are rotated from one week to the next and that the two injections administered weekly to constitute the recommended dose of HIBSAGO are separated by at least 2 inches (5 cm).” (opens the prescribing information at this quote)

Storage and handling after dispensing

“Prior to Dispensing: Store in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Store in the original carton to protect from light. Do not shake.” (opens the prescribing information at this quote)
“Following Dispensing: Store HIBSAGO at room temperature up to 86°F (30°C) for 12 weeks.” (opens the prescribing information at this quote)
“Discard if the expiry date has passed, or it has been 12 weeks since carton was received, whichever comes first.” (opens the prescribing information at this quote)
“HIBSAGO injection must be administered within 6 hours once removed from the carton. Discard if not administered within 6 hours.” (opens the prescribing information at this quote)

Instructions for Use: preparation, injection, and disposal steps

“Make sure HIBSAGO has been at room temperature up to 86°F (30°C) for at least 30 minutes before using it. Cold medicine is more painful to inject.” (opens the prescribing information at this quote)
“If you are giving yourself the injection, you can inject into your thighs or stomach (abdomen).” (opens the prescribing information at this quote)
“A caregiver can inject into the upper arm, thigh, or abdomen.” (opens the prescribing information at this quote)
“Do not inject yourself in the upper arm.” (opens the prescribing information at this quote)
“Inject within 5 minutes after you remove the gray needle cap.” (opens the prescribing information at this quote)
“Hold the middle of the syringe and insert the entire needle into the pinched skin at a 45-degree angle using a dart like motion, as shown.” (opens the prescribing information at this quote)
“Make sure the white plunger is pushed all the way down until the stopper reaches the bottom of the syringe and all of the medicine is injected.” (opens the prescribing information at this quote)
“For a 300 mg dose, give your second injection immediately, to complete your dose, by repeating all Inject steps (Steps B1 through B5).” (opens the prescribing information at this quote)
“Put your used HIBSAGO syringe(s) and gray needle cap(s) in an FDA-cleared sharps disposal container right away.” (opens the prescribing information at this quote)

Patient counseling on administration technique

“Train patients and caregivers on the importance of proper subcutaneous administration technique, the necessity of rotating injection sites and how to use the prefilled syringe. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use HIBSAGO” (opens the prescribing information at this quote)

Self-administration with the prefilled syringe: relative bioavailability study

“Participants (N = 159) received a single 300 mg SC dose of bepirovirsen administered by a HCP (vial [n = 46] or PFS SSD [n = 49]), or self‐administered (PFS SSD, with [n = 32] or without [n = 32] training from a HCP).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“The GMR (90% CI) with participant training (Group 2 versus Group 3) was 1.02 (0.88, 1.18) for Cmax and 0.98 (0.88, 1.09) for AUC(0‐inf), and without participant training (Group 2 versus Group 4) was 0.99 (0.87, 1.13) for Cmax and 0.97 (0.87, 1.08) for AUC(0‐inf).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“The proportion of participants experiencing injection site reactions was higher when PFS SSD was self‐administered (Group 3: 32/32 [100%], Group 4: 30/32 [94%]) compared with HCP administration (Group 2: 43/49 [88%]).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“While 6 participants received an incomplete dose of bepirovirsen, owing to incorrect use of the PFS (4 of them injected approximately 75% to 95% of the dose), device usability was evaluated in separate formative and summative human factors studies, and the device and instructions for use were successfully validated for self‐administration (unpublished data).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

Injection site and exposure

“Bepirovirsen exposure differed by SC injection site, with lower exposure observed when the SC injection was administered in the thigh compared with the abdomen or upper arm.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote