DARZALEX (Page 7 of 8)

15 REFERENCES

  1. Chapuy, CI, RT Nicholson, MD Aguad, et al., 2015, Resolving the daratumumab interference with blood compatibility testing, Transfusion, 55:1545–1554 (accessible at http://onlinelibrary.wiley.com/doi/10.1111/trf.13069/epdf).

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

DARZALEX® (daratumumab) injection is a colorless to pale yellow, preservative-free solution for intravenous infusion.

NDC 57894-502-05 and NDC 57894-505-05 each contain one 100 mg/5 mL single-dose vial

NDC 57894-502-20 and NDC 57894-505-20 each contain one 400 mg/20 mL single-dose vial

Storage and Stability

Store in a refrigerator at 2°C to 8°C (36°F to 46°F).

Do not freeze or shake. Protect from light. This product contains no preservative.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Infusion-Related Reactions

Advise patients to seek immediate medical attention for any of the following signs and symptoms of infusion-related reactions: itchy, runny or blocked nose; fever, chills, nausea, vomiting, throat irritation, cough, headache, dizziness or lightheadedness, tachycardia, chest discomfort, wheezing, shortness of breath or difficulty breathing, itching, and blurred vision [see Warnings and Precautions (5.1)].

Neutropenia

Advise patients to contact their healthcare provider if they have a fever [see Warnings and Precautions (5.3)].

Thrombocytopenia

Advise patients to contact their healthcare provider if they notice signs of bruising or bleeding [see Warnings and Precautions (5.4)].

Interference with Laboratory Tests

Advise patients to inform their healthcare providers, including personnel at blood transfusion centers that they are taking DARZALEX, in the event of a planned transfusion [see Warnings and Precautions (5.2)].

Advise patients that DARZALEX can affect the results of some tests used to determine complete response in some patients and additional tests may be needed to evaluate response [see Warnings and Precautions (5.5)].

Hepatitis B Virus (HBV) Reactivation

Advise patients to inform healthcare providers if they have ever had or might have a hepatitis B infection and that DARZALEX could cause hepatitis B virus to become active again [see Adverse Reactions (6.1)].

Embryo-Fetal Toxicity

Advise pregnant women of the potential hazard to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6), Use in Specific Populations (8.1, 8.3)].

Advise females of reproductive potential to avoid becoming pregnant during treatment with DARZALEX and for 3 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

Advise patients that lenalidomide, pomalidomide, or thalidomide has the potential to cause fetal harm and has specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm. Lenalidomide, pomalidomide, and thalidomide are only available through a REMS program [see Use in Specific Populations (8.1, 8.3)].

Hereditary Fructose Intolerance (HFI)

DARZALEX contains sorbitol. Advise patients with HFI of the risks related to sorbitol [see Description (11)].

Manufactured by:
Janssen Biotech, Inc.
Horsham, PA 19044U.S. License Number 1864

© 2015–2021 Janssen Pharmaceutical Companies

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 3/2022
PATIENT INFORMATIONDARZALEX® (Dar’-zah-lex)(daratumumab)injection, for intravenous use
What is DARZALEX? DARZALEX is a prescription medicine used to treat adults with multiple myeloma:
  • in combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people whose multiple myeloma has come back or did not respond to treatment who have received at least one prior medicine to treat multiple myeloma.
  • in combination with the medicines bortezomib, melphalan and prednisone, in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).
  • in combination with the medicines bortezomib, thalidomide, and dexamethasone in newly diagnosed people who are eligible to receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).
  • in combination with the medicines bortezomib and dexamethasone, in people who have received at least one prior medicine to treat multiple myeloma.
  • in combination with the medicines carfilzomib and dexamethasone, in people whose multiple myeloma has come back or did not respond to treatment who have received one to three prior medicines to treat multiple myeloma.
  • in combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor.
  • alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent.
It is not known if DARZALEX is safe and effective in children.
Do not receive DARZALEX:
  • if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX. See the end of this leaflet for a complete list of ingredients in DARZALEX.
Before you receive DARZALEX, tell your healthcare provider about all of your medical conditions, including if you:
  • have a history of breathing problems.
  • have had shingles (herpes zoster).
  • have ever had or might now have a hepatitis B infection as DARZALEX could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during and for some time after treatment with DARZALEX. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes.
  • have hereditary fructose intolerance (HFI). DARZALEX contains sorbitol. Sorbitol is a source of fructose. People with HFI cannot break down fructose, which may cause serious side effects.
  • are pregnant or plan to become pregnant. DARZALEX may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with DARZALEX.
    • Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment and for 3 months after your last dose of DARZALEX. Talk to your healthcare provider about birth control methods that you can use during this time.
    • 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.
      • The lenalidomide, pomalidomide, and thalidomide REMS has more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant.
      • For males who have female partners who can become pregnant, there is information in the lenalidomide, pomalidomide, and thalidomide REMS about sperm donation and how lenalidomide, pomalidomide, and thalidomide can pass into human semen.
  • are breastfeeding or plan to breastfeed. It is not known if DARZALEX passes into your breast milk. You should not breastfeed during treatment with DARZALEX. Talk to your healthcare provider about the best way to feed your baby during treatment with DARZALEX.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive DARZALEX?
  • DARZALEX may be given alone or together with other medicines used to treat multiple myeloma.
  • DARZALEX will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
  • Your healthcare provider will decide the time between doses as well as how many treatments you will receive.
  • Your healthcare provider will give you medicines before each dose of DARZALEX and after each dose of DARZALEX to help reduce the risk of infusion-related reactions.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
What are the possible side effects of DARZALEX?DARZALEX may cause serious reactions, including:
  • Infusion-related reactions. Infusion-related reactions are common with DARZALEX. Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death, can happen with DARZALEX. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX if you have infusion-related reactions. Get medical help right away if you get any of the following symptoms:
  • 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 or irritation
  • runny or stuffy nose
  • headache
  • itching
  • high blood pressure
  • nausea
  • vomiting
  • chills
  • fever
  • chest discomfort
  • blurred vision
  • Changes in blood tests. DARZALEX 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 of DARZALEX. Your healthcare provider will do blood tests to match your blood type before you start treatment with DARZALEX. Tell all of your healthcare providers that you are being treated with DARZALEX before receiving blood transfusions.
  • Decreases in blood cell counts. DARZALEX 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 with DARZALEX. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding.
The most common side effects of DARZALEX include:
  • tiredness
  • nausea
  • diarrhea
  • shortness of breath
  • feeling weak
  • fever
  • cough
  • cold-like symptoms (upper respiratory infection)
  • nerve damage causing tingling, numbness or pain
  • swollen hands ankles or feet
  • constipation
These are not all the possible side effects of DARZALEX.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of DARZALEX Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about DARZALEX that is written for health professionals.
What are the ingredients in DARZALEX? Active ingredient: daratumumabInactive ingredients: may include glacial acetic acid, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, sorbitol, and water for injection.Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044 U.S. License Number 1864For more information, call 1-800-526-7736 or go to www.DARZALEX.com.

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