• Multiple myeloma in patients who have received 1 prior therapy (in combination with bortezomib and dexamethasone).
• Relapsed or refractory multiple myeloma in patients who have received 1 prior therapy (in combination with lenalidomide and dexamethasone).
• Multiple myeloma in patients who have received 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.
• Newly diagnosed multiple myeloma in patients who are ineligible for autologous stem cell transplant (in combination with bortezomib, melphalan, and prednisone).
• Newly diagnosed multiple myeloma in patients who are ineligible for autologous stem cell transplant (in combination with lenalidomide and dexamethasone).
• Newly diagnosed multiple myeloma in patients who are eligible for autologous stem cell transplant (in combination with bortezomib, thalidomide, and dexamethasone).
• Newly diagnosed light chain amyloidosis (in combination with bortezomib, cyclophosphamide, and dexamethasone).

Contraindicated in:

• Severe hypersensitivity
• OB: May cause fetal harm
• Lactation: Lactation.

Use Cautiously in:

• Cardiovascular disease (for light chain amyloidosis only)
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: CARDIAC ARREST, HF, hypertension, hypotension, peripheral edema, atrial fibrillation.

Derm: pruritus, rash.

Endo: hyperglycemia.

F and E: hypocalcemia.

GI: abdominal pain, constipation, diarrhea, nausea, vomiting.

Hemat: NEUTROPENIA, anemia, leukopenia, lymphocytopenia, thrombocytopenia.

Local: injection site reactions.

Metab: ↓appetite.

MS: muscle spasms, arthralgia.

Neuro: peripheral neuropathy, paresthesia , dizziness, insomnia, headache.

Resp: cough, dyspnea, pulmonary edema.

Misc: hypersensitivity reactions (including anaphylaxis), INFECTION, fatigue, fever, infusion reactions.

Drug-Drug:

• None reported.

• Solution for injection: daratumumab 120 mg and hyaluronidase 2,000 units/mL;

Multiple Myeloma — Monotherapy and Combination Therapy with Lenalidomide and Dexamethasone

• SC (Adults): Daratumumab 1,800 mg/hyaluronidase 30,000 units once weekly starting at Week 1 through Week 8 (total of 8 doses), then daratumumab 1,800 mg/hyaluronidase 30,000 units every 2 wk starting at Week 9 until Week 24 (total of 8 doses), then daratumumab 1,800 mg/hyaluronidase 30,000 units every 4 wk starting at Week 25 and onward; continue until disease progression.

Multiple Myeloma — Combination Therapy with Bortezomib, Melphalan, and Prednisone

• SC (Adults): Daratumumab 1,800 mg/hyaluronidase 30,000 units once weekly starting at Week 1 through Week 6 (total of 6 doses), then daratumumab 1,800 mg/hyaluronidase 30,000 units every 3 wk starting at Week 7 until Week 54 (total of 16 doses), then daratumumab 1,800 mg/hyaluronidase 30,000 units every 4 wk starting at Week 55 and onward; continue until disease progression.

Multiple Myeloma — Combination Therapy with Bortezomib, Thalidomide, and Dexamethasone

• SC (Adults): Induction therapy — Daratumumab 1,800 mg/hyaluronidase 30,000 units once weekly starting at Week 1 through Week 8 (total of 8 doses), then daratumumab 1,800 mg/hyaluronidase 30,000 units every 2 wk starting at Week 9 until Week 16 (total of 4 doses), then stop for high-dose chemotherapy and autologous stem cell transplant; Consolidation therapy — Daratumumab 1,800 mg/hyaluronidase 30,000 units every 2 wk starting at Week 1 upon reinitiation of treatment following autologous stem cell transplant and continued until Week 8 (total of 4 doses).

Multiple Myeloma — Combination Therapy with Bortezomib and Dexamethasone

• SC (Adults): Daratumumab 1,800 mg/hyaluronidase 30,000 units once weekly starting at Week 1 through Week 9 (total of 9 doses), then daratumumab 1,800 mg/hyaluronidase 30,000 units every 3 wk starting at Week 10 until Week 24 (total of 5 doses), then daratumumab 1,800 mg/hyaluronidase 30,000 units every 4 wk starting at Week 25 and onward; continue until disease progression.

Light Chain Amyloidosis — Combination Therapy with Bortezomib, Cyclophosphamide, and Dexamethasone

• SC (Adults): Daratumumab 1,800 mg/hyaluronidase 30,000 units once weekly starting at Week 1 through Week 8 (total of 8 doses), then daratumumab 1,800 mg/hyaluronidase 30,000 units every 2 wk starting at Week 9 until Week 24 (total of 8 doses), then daratumumab 1,800 mg/hyaluronidase 30,000 units every 4 wk starting at Week 25 and onward; continue until disease progression or a maximum of 2 yr.

Darzalex Faspro

• Daratumumab — Binds to CD38 on tumor cells causing apoptosis, thereby inhibiting growth of CD38-expressing tumor cells.Hyaluronidase — acts locally by depolymerizing hyalyonan, which increases permeability of the subcutaneous tissue.

• Decreased progression of multiple myeloma.
• Decreased progression of light chain amyloidosis.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Absorption: 69% absorbed following subcutaneous administration.

Distribution: Monoclonal antibodies cross the placenta.

Metabolism/Excretion: Unknown.

Half-life: 20 days.

(blood levels)

• Explain purpose of daratumumab/hyaluronidase to patient. Instruct patient to read the Patient Information sheet prior to therapy.
• Advise patient to notify health care professional immediately if signs and symptoms of infusion reactions (itchy, runny, or blocked nose; chills, nausea, throat irritation, cough, headache, shortness of breath, difficulty breathing), bleeding, bruising, or fever occur.
• Advise patients to notify health care professional if they have ever had or might have a hepatitis B infection. Daratumumab/hyaluronidase may cause reactivation of hepatitis B virus.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise patient to inform health care professionals of medication regimen, including personnel at blood transfusion centers.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 3 months after last dose and to avoid breastfeeding during therapy. Advise patient to notify health care professional if pregnancy is suspected.

dar-a-TOOM-ue-mab/hye-al-yoor-ON-i-dase