Expand your frontline frontiers with DARZALEX FASPRO^®
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Lorem ipsum dolor sit amet consectetur adipiscing elit. Quisque faucibus ex sapien vitae pellentesque sem placerat. In id cursus mi pretium tellus duis convallis. Tempus leo eu aenean sed diam urna tempor. Pulvinar vivamus fringilla lacus nec metus bibendum egestas. Iaculis massa nisl malesuada lacinia integer nunc posuere. Ut hendrerit semper vel class aptent taciti sociosqu. Ad litora torquent per conubia nostra inceptos himenaeos.

Lorem ipsum dolor sit amet consectetur adipiscing elit. Quisque faucibus ex sapien vitae pellentesque sem placerat. In id cursus mi pretium tellus duis convallis. Tempus leo eu aenean sed diam urna tempor. Pulvinar vivamus fringilla lacus nec metus bibendum egestas. Iaculis massa nisl malesuada lacinia integer nunc posuere. Ut hendrerit semper vel class aptent taciti sociosqu. Ad litora torquent per conubia nostra inceptos himenaeos.

Lorem ipsum dolor sit amet consectetur adipiscing elit. Quisque faucibus ex sapien vitae pellentesque sem placerat. In id cursus mi pretium tellus duis convallis. Tempus leo eu aenean sed diam urna tempor. Pulvinar vivamus fringilla lacus nec metus bibendum egestas. Iaculis massa nisl malesuada lacinia integer nunc posuere. Ut hendrerit semper vel class aptent taciti sociosqu. Ad litora torquent per conubia nostra inceptos himenaeos.

Lorem ipsum dolor sit amet consectetur adipiscing elit. Quisque faucibus ex sapien vitae pellentesque sem placerat. In id cursus mi pretium tellus duis convallis. Tempus leo eu aenean sed diam urna tempor. Pulvinar vivamus fringilla lacus nec metus bibendum egestas. Iaculis massa nisl malesuada lacinia integer nunc posuere. Ut hendrerit semper vel class aptent taciti sociosqu. Ad litora torquent per conubia nostra inceptos himenaeos.

Lorem ipsum dolor sit amet consectetur adipiscing elit. Quisque faucibus ex sapien vitae pellentesque sem placerat. In id cursus mi pretium tellus duis convallis. Tempus leo eu aenean sed diam urna tempor. Pulvinar vivamus fringilla lacus nec metus bibendum egestas. Iaculis massa nisl malesuada lacinia integer nunc posuere. Ut hendrerit semper vel class aptent taciti sociosqu. Ad litora torquent per conubia nostra inceptos himenaeos.

00:00:05

F: Darzalex Faspro, daratumumab and hyaluronidase, is a subcutaneous formulation approved for the treatment of a wide range of patients with multiple myeloma.

00:00:14

Indications: Darzalex Faspro, daratumumab and hyaluronidase, is indicated for the treatment of adult patients with multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant; in combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant; in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor, PI; in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; as monotherapy in patients who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent.

00:01:49

[Select Important Safety Information]

00:02:36

F: Darzalex Faspro contains recombinant hyaluronidase, a substance that increases the permeability of subcutaneous tissue making it possible for 15 ml of daratumumab to be administered subcutaneously in approximately three to five minutes by a healthcare provider. It is available in a single dose vial with no dilution needed and Darzalex Faspro offers the same dosing schedule as Darzalex, daratumumab, for the approved indications. Please note the split first dose option for Darzalex is not applicable to Darzalex Faspro.

00:03:13

Darzalex Faspro is for subcutaneous use only. Do not administer intravenously. Premedicate patients one to three hours before each dose with a histamine-1 receptor antagonist, acetaminophen, and a corticosteroid. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reactions or life-threatening grade 4 administration-related reactions, immediately and permanently discontinue Darzalex Faspro.

00:03:45

Darzalex Faspro contains 1,800 mg of daratumumab and 30,000 units of hyaluronidase in a 15 ml solution. Store Darzalex Faspro vials in a refrigerator at two degrees Celsius to eight degrees Celsius, 36 degrees Fahrenheit to 46 degrees Fahrenheit, in the original carton to protect from light. Do not freeze or shake.

00:04:08

Before you begin, collect the supplies. You’ll need a vial of Darzalex Faspro, a 20-ml syringe, an appropriate gauge transfer needle per institution or practice protocol, and injection needles; 23-to-25-gauge injection needles were used in clinical trials for administration of Darzalex Faspro. If you prefer, you may use a winged infusion set to administer Darzalex Faspro. Also, gather any materials needed to adhere to aseptic guidelines in your facility.

00:04:39

First, remove the Darzalex Faspro vial from the refrigerator and allow to equilibrate to ambient temperature. Then, check the liquid in the vial. Keep the vial out of direct sunlight and do not shake. To prevent medication errors, it is important to check the vial labels and expiration to ensure that the drug being administered is Darzalex Faspro for subcutaneous injection and not Darzalex, daratumumab, which is given intravenously.

00:05:09

Visually inspect the vial contents and expiration. Do not use if opaque particles, discoloration, or other foreign particles are present.

00:05:19

Prepare the dosing syringe in controlled and validated aseptic conditions. If the syringe containing Darzalex Faspro is not used immediately, store the solution of Darzalex Faspro in the syringe for up to four hours at ambient temperature and ambient light. Discard after four hours if not used.

00:05:40

Using the transfer needle, withdraw the full content of the vial into a 20-ml dosing syringe. After transferring Darzalex Faspro, inspect dosing syringe visually for particulate matter and discoloration. Do not administer if opaque particles, discoloration, or other foreign particles are present.

00:06:00

After the solution is withdrawn into the syringe, replace the transfer needle with a syringe closing cap. Label the syringe appropriately to include the route of administration per institutional standards. Label the syringe with the peel-off label.

00:06:16

Darzalex Faspro makes subcutaneous administration possible starting with the first dose.

00:06:25

00:06:30

Choose the injection site on the abdomen. Rotate injection sites for each successive injection. Do not inject into skin on the abdomen that is tender, bruised, red, hard, or has scars. Select a site on the abdomen approximately three inches or seven centimeters to the right or left of the navel and cleanse the area. Wipe your chosen injection site with an alcohol swab and allow it to dry.

00:06:56

Remove the syringe closing cap and attach the injection needle to the syringe. To avoid clogging, perform this step immediately prior to injection. Prime the syringe and set the dose to 15 ml. When you and your patient are comfortable, start the injection. Pinch a two-inch fold of cleansed skin at the injection site on the abdomen. It is important to pinch enough skin to inject under the skin and not into the muscle.

00:07:25

Insert needle with a quick, dart-like motion at a 45-degree angle. Try to limit needle and syringe movement during the injection. If using a winged infusion set, secure with bandage if needed. Inject 15 ml of Darzalex Faspro into the subcutaneous tissue of the abdomen. Press the plunger with a constant rate of administration for approximately three to five minutes. If the patient feels pain, pause or slow down the rate of administration. If the patient still feels pain, consider using a different injection site on the opposite side of the abdomen to deliver the remainder of the dose.

00:08:04

Do not inject Darzalex Faspro at other sites of the body as no data are available. Injection sites should be rotated for successive injections. Do not administer other medications for subcutaneous use at the same site.

00:08:19

Depending on the dosing regimen and medical history, consider administering corticosteroids and other medications after the administration of Darzalex Faspro to minimize the risk of delayed systemic administration-related reactions which can occur 24 hours after administration. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening grade 4 administration-related reactions, immediately and permanently discontinue Darzalex Faspro.

00:08:53

In clinical trials, the term infusion reactions was used instead of systemic administration-related reactions. The term systemic administration-related reactions is used because Darzalex Faspro is not given by intravenous infusion.

00:09:09

Severe reactions include hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.

00:09:46

Most systemic administration-related reactions were grade 1 or 2 and occurred with the first injection. The most common systemic administration-related reactions with Darzalex Faspro compared with Darzalex, daratumumab, were chills at 5% versus 12%, pyrexia at 5% versus 3%, and dyspnea at 1% versus 7% respectively. Grade 3 systemic administration-related reactions occurred in 2% of patients using Darzalex Faspro compared with 5% of those on Darzalex. No grade 4 systemic administration-related reactions were reported.

00:10:24

Systemic ARRs causing severe reactions include hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.

00:11:03

In a pooled safety population of 1,249 patients, the rate of systemic administration-related reactions was 7% for Darzalex Faspro. The median time to onset of systemic administration-related reactions following an injection of Darzalex Faspro was 2.9 hours, with a range of five minutes to 3.5 days. The majority of systemic administration-related reactions occurred on the day of treatment. Delayed systemic administration-related reactions, which were those occurring after the day of administration, have occurred in less than 1% of patients. These local reactions occurred a median of five minutes, range zero minutes to 6.5 days, after starting administration of Darzalex Faspro.

00:11:49

The incidence of any grade systemic administration-related reactions was 7% with the first injection of Darzalex Faspro at week one, 0.2% with the second injection at week two, and cumulatively 1% with subsequent injections. In this pooled safety population, 7% of patients had local injection-site reactions, with injection site erythema being the most frequent and occurring in less than 1% of patients. Monitor for local reactions and consider symptomatic management.

00:12:21

Darzalex Faspro offers eight approved indications, three-to-five-minute administration, and a ready-to-use vial. In pooled clinical trials, Darzalex Faspro demonstrated a 7% rate of administration-related reactions.

00:12:36

[Indications]

00:14:09

[Important Safety Information]

00:21:56