Darzalex Faspro

Darzalex Faspro subcutaneous injection is a CD38-directed cytolytic antibody used to treat multiple myeloma and light-chain amyloidosis in certain patients. Darzalex Faspro can be used alone as a single therapy, but is often used together with other medicines, depending on your diagnosis and previous treatments.

Darzalex Faspro works by binding to CD38, a protein on multiple myeloma cancer cells, which causes myeloma cells to die. It also activates the immune system to fight myeloma more effectively.

Darzalex Faspro is a CD38 monoclonal antibody.

Darzalex Faspro (daratumumab and hyaluronidase-fihj) is given as an injection under the skin over three to five minutes. Darzalex Faspro is a different product from Darzalex. Darzalex contains the active ingredient daratumumab and is given intravenously over a period of hours. It is used to treat specific multiple myeloma patients, not light chain amyloidosis.

The difference between Darzalex Faspro and Darzalex is that Darzalex Faspro only takes minutes to administer compared to Darzalex, which takes hours. This is because Darzalex Faspro has an extra ingredient (hyaluronidase-fihj) in it, so it can be given as a subcutaneous injection, whereas Darzalex needs to be given as an intravenous infusion. Darzalex is indicated only for multiple myeloma in certain patients, and Darzalex Faspro can treat multiple myeloma patients and also treat adults with newly diagnosed light chain (AL) amyloidosis.

• Hypersensitivity and Other Administration Reactions: This medicine may cause life-threatening hypersensitivity reactions.
• Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis: Patients with cardiac involvement should be monitored more frequently for cardiac adverse reactions.
• Infections: This medicine can cause serious and fatal infections. Tell your healthcare provider right away if you develop any signs or symptoms of infection.
• Neutropenia: A low number of neutrophils, a type of white blood cell that fights infection.
• Thrombocytopenia: A low level of platelets in the blood, which increases the risk of bleeding into the tissues, bruising, and slow blood clotting after injury.
• Embryo-Fetal Toxicity: This medicine can cause fetal harm. Advise pregnant women of the potential risk to the fetus and advise females of reproductive potential to use effective contraception.
• Interference with Cross-Matching and Red Blood Cell Antibody Screening: Type and screen patients prior to starting treatment. Inform blood banks that the patient has received this medicine.

For more information about these warnings and precautions, see the Side Effects section.

Darzalex Faspro J code is J9144 (Injection, daratumumab, 10 mg and hyaluronidase-fihj).

J codes are important, accurate, and consistent coding for billing and reimbursement purposes. J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. Your physician will need the Darzalex Faspro J-code when filling out forms for your treatment.

Review the full Darzalex Faspro package insert for more detailed information about this medicine. The Darzalex Faspro Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all of the information you need to know about Darzalex for safe and effective use and does not take the place of talking to your doctor about your treatment.

The package insert is sometimes called Darzalex Faspro Prescribing Information (PI) or the FDA label.

You should not receive this medicine if you have a history of a severe allergic reaction to daratumumab, hyaluronidase or any of the ingredients in Darzalex Faspro. See the end of this page for a complete list of ingredients.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• a breathing disorder; or
• herpes zoster (also called shingles) you may be prescribed antiviral medicine to prevent reactivation of shingles.
• hepatitis B as hepatitis B virus may become active again. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or the white part of your eyes.
• have hereditary fructose intolerance (HFI). This medicine contains sorbitol which is a source of fructose. People with HFI cannot break down fructose, which may cause serious side effects.

Before you receive Darzalex Faspro for light chain (AL) amyloidosis, tell your healthcare provider if you have a history of heart problems. Darzalex Faspro should not be used in light chain (AL) amyloidosis patients with highly advanced heart disease outside of clinical trials.

Pregnancy

Darzalex

• Daratumumab may harm an unborn baby.
• Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with this medicine.
• Females who are able to become pregnant should use an effective method of birth control during treatment and for 3 months after their last dose of Darzalex Faspro. Talk to your healthcare provider about birth control methods that you can use during this time.

Darzalex in combination with lenalidomide, pomalidomide, or thalidomide.

• Both men and women using these other drugs must use effective birth control. Even one dose can cause severe, life-threatening birth defects or death of a baby, if the mother or the father is taking lenalidomide, pomalidomide, or thalidomide at the time of conception or during pregnancy.
• Before starting Darzalex in combination with lenalidomide, pomalidomide, or thalidomide, females and males must agree to the instructions in the lenalidomide, pomalidomide, or thalidomide REMS program.

Breastfeeding

If you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You should not breastfeed during treatment with this medicine. Talk to your healthcare provider about the best way to feed your baby during treatment with Darzalex Faspro.

Darzalex Faspro is administered as an injection under the skin, in the stomach area (abdomen) by your healthcare provider, which takes 3 to 5 minutes.

Your healthcare provider will decide the time between doses and how many treatments you will receive.

Your healthcare provider will give you medicines before and after injection to help reduce and prevent serious side effects or an allergic reaction (infusion-related reactions). Darzalex Faspro may be given alone (monotherapy) or together with other medicines used to treat multiple myeloma.

You will need frequent medical tests while having treatment with this medicine.

Common Darzalex Faspro side effects

The most common side effects of Darzalex Faspro, when used on its own, include cold-like symptoms, muscle, bone, and joint pain, tiredness, diarrhea, rash, trouble sleeping, nerve problems, and injection site reactions.

Common Darzalex Faspro side effects when used in combination therapy include tiredness, nausea, diarrhea, constipation, shortness of breath, trouble sleeping, fever, cough, muscle spasms, back pain, vomiting, cold-like symptoms (upper-respiratory infection), nerve damage causing tingling, numbness or pain, lung infection (pneumonia), swollen hands, ankles, or feet, headache, high blood pressure and decreased red blood cell counts.

Serious Darzalex Faspro side effects

Darzalex Faspro may cause serious reactions, including serious allergic reactions and other severe injection-related reactions. Serious allergic reactions and reactions due to the release of certain substances by your body (systemic) that can lead to death can happen with Darzalex Faspro.

Other serious side effects can occur; tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an injection of Darzalex Faspro.

• shortness of breath or trouble breathing
• dizziness or lightheadedness (hypotension)
• cough
• wheezing
• heart beating faster than usual
• low oxygen in the blood (hypoxia)
• throat tightness
• runny or stuffy nose
• headache
• itching
• high blood pressure
• nausea
• vomiting
• chills
• fever
• chest pain
• blurred vision
• eye pain

Injection site reactions. Skin reactions at or near the injection site (local), including injection site reactions, can happen with Darzalex Faspro. Symptoms at the site of injection may include itching, swelling, bruising, pain, rash, bleeding, or redness of the skin. These reactions sometimes happen more than 24 hours after an injection of Darzalex Faspro.

Heart problems in people with light chain (AL) amyloidosis. Heart problems, in some cases fatal, have occurred. Your healthcare provider will monitor you closely during treatment. Call your healthcare provider right away if you get any of the following symptoms: chest pain, feeling faint, swollen legs, shortness of breath, or abnormal heart rhythm.

Infections. Darzalex Faspro can cause serious life-threatening infections that can lead to death. Tell your healthcare provider right away if you develop a fever, trouble breathing, cough, burning or pain when you urinate, or any other signs and symptoms of infection during treatment.

Decreases in blood cell counts. Darzalex Faspro can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. Your healthcare provider will check your blood cell counts during treatment. Tell your healthcare provider if you develop a fever or have signs of bruising or bleeding.

Changes in blood tests. Darzalex Faspro can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose. Your healthcare provider will do blood tests to match your blood type before you start treatment. Tell all of your healthcare providers that you are being treated with Darzalex Faspro before receiving blood transfusions.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Multiple Myeloma

• Newly diagnosed multiple myeloma (NDMM) Eligible for autologous stem cell transplant Darzalex Faspro (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d) = DVRd (for induction and consolidation). Darzalex Faspro (D) + bortezomib (V) + thalidomide (T) + dexamethasone (d) = DVTd. Ineligible for autologous stem cell transplant Darzalex Faspro (D) + bortezomib (V) + melphalan (M) + prednisone (P) = DVMP. Darzalex Faspro (D) + lenalidomide (R) + dexamethasone (d) = DRd. Darzalex Faspro (D) + bortezomib (V), lenalidomide (R), dexamethasone (d) = DVRd
• Relapsed or refractory multiple myeloma After ≥1 prior therapy Darzalex Faspro (D)+ lenalidomide (R) + dexamethasone (d) = DRd. Darzalex Faspro (D) + bortezomib (V) + dexamethasone (d) = DVd. Darzalex Faspro (D)+ pomalidomide (P) + dexamethasone (d) = DPd. Prior line of therapy, including lenalidomide and a proteasome inhibitor (PI). After 1-3 prior lines of therapy Darzalex Faspro (D) + carfilzomib (K) + dexamethasone (d) = DKd. After ≥3 prior therapies Darzalex Faspro monotherapy. in patients who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
• High-risk smoldering multiple myeloma (SMM) in adults Darzalex Faspro as monotherapy

Light chain (AL) amyloidosis

• In newly diagnosed patients Darzalex Faspro (D) + Bortezomib (V) + cyclophosphamide (C) + dexamethasone (d) = D-VCd. Limitations of Use: This medicine is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials

Usual Adult Darzalex Faspro Dosage Schedule for Multiple Myeloma

Dose: 1800 mg/30,000 units (1800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over approximately 3 to 5 minutes.Darzalex Faspro dosing scheduleFor monotherapy or in combination with lenalidomide/ dexamethasone, pomalidomide/dexamethasone, or carfilzomib and dexamethasone.-Weeks 1 to 8: weekly (total of 8 doses)-Weeks 9 to 24: every 2 weeks (total of 8 doses), the first dose of the every-2-week dosing schedule is given at Week 9.-Week 25 onward until disease progression: every 4 weeks, the first dose of the every-4-week dosing schedule is given at Week 25.

Comments-Consult the manufacturer product information for dosing as part of other combination therapies.-Premedicate patients with acetaminophen 650 to 1000 mg orally, diphenhydramine 25 to 50 mg (or equivalent) orally or IV, and a corticosteroid (long- or intermediate-acting) such as methylprednisolone 100 mg (or equivalent) oral or IV. Consider reducing the dose of methylprednisolone to 60 mg (or equivalent) following the second dose of this drug.-Post medicate patients with methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days starting the day after the administration of this drug.-Consult the manufacturer's prescribing information for pre-medication and post-medication recommendations when used as part of a combination therapy.

Darzalex Faspro dosing schedules in combination with other medications

For multiple myeloma, Darzalex Faspro dosing schedules when used in combination with other medications, see the specific Darzalex Faspro dosing page.

Usual Adult Darzalex Faspro Dose for Light Chain Amyloidosis

Dose: 1800 mg/30,000 units (1800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over approximately 3 to 5 minutes.

Comments:-Consult the manufacturer's product information for dosing as part of other combination therapies.-Premedicate patients with acetaminophen 650 to 1000 mg orally, diphenhydramine 25 to 50 mg (or equivalent) orally or IV, and a corticosteroid (long- or intermediate-acting) such as methylprednisolone 100 mg (or equivalent) oral or IV. Consider reducing the dose of methylprednisolone to 60 mg (or equivalent) following the second dose of this drug.-Post medicate patients with methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days starting the day after the administration of this drug.-Consult the manufacturer's prescribing information for pre-medication and post-medication recommendations when used as part of a combination therapy.

Vial

• Store vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light.
• Before using medicine equilibrate vial to ambient temperature [15°C to 30°C (59°F to 86°F)]
• Store the unpunctured vial at ambient temperature and ambient light for a maximum of 24 hours. Keep out of direct sunlight. Do not shake.
• Do not freeze or shake.

Drawn up syringe

• If the syringe containing Darzalex Faspro is not used immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours and/or at room temperature at 15°C to 25°C (59°F to 77°F) for up to 12 hours under ambient light.
• Discard if storage time exceeds these limits.
• If stored in the refrigerator, allow the solution to come to room temperature before administration.

Active ingredient: daratumumab and hyaluronidase-fihjInactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol, and water for injection.

Darzalex Faspro manufacturer Janssen Biotech, Inc., Horsham, PA 19044, USA.