What is Daratumumab and hyaluronidase?
Daratumumab and hyaluronidase are used to treat multiple myeloma among adults. Daratumumab can be used in combination with hyaluronidase to treat adults suffering from light-chain amyloidosis. Daratumumab hyaluronidase can be used with other medications. Daratumumab or hyaluronidase can be used in other ways not mentioned in this guide.
Side effects of Daratumumab and hyaluronidase
If you experience any of the following symptoms, seek emergency medical attention: itching, hives, runny nose or stuffy nasal passages, fever, chills, and headaches; nausea, vomiting, throat irritation; chest pain; wheezing; difficulty breathing; swelling in your face, lips, or throat; or throat, lip, tongue, or face. Some side effects can occur before or after the injection. You should tell your doctor if you experience nausea, dizziness, lightheadedness, itching, sweating, headaches, chest pain or back pain, or a swelling of your face.
Daratumumab or hyaluronidase can cause serious side effects. If you experience:
- A feeling of lightheadedness, as if you could pass out.
- Easy bruising, unusual bleeding, or purple or red patches under the skin
- Right-sided upper abdominal pain, vomiting, loss of appetite, yellowing skin or eyes, and feeling unwell
- Heart problems: chest pain, feeling weak, shortness of breath, and swollen legs.
- Low blood cell counts include fever, easy bruising, and unusual bleeding.
- A lung infection is characterized by fever, chills, and a mucus-filled cough.
If you experience certain side effects, your cancer treatment may be discontinued or delayed.
Daratumumab side effects may include:
- Swollen ankles or feet, hands, or even the fingers
- Itching, swelling, bruising, or redness at the injection site;
- Nausea, vomiting, diarrhea, constipation;
- Fever and low blood cell count
- A severe headache can cause blurred vision or a pounding sensation in the neck, ears, or head.
- Cough, lung infection, and difficulty breathing;
- You may experience tingling or burning in your feet or hands.
- Tiredness;
- Sore or stuffy throat.
- Muscle spasm; back pain
- Sleep problems (insomnia).
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Warnings
Use birth-control methods while taking daratumumab or hyaluronidase, and for 3 months following your last dose. Follow all instructions regarding birth control when using Daratumumab or hyaluronidase with other medications.
Before you take this drug
This medicine should not be used if you have an allergy to daratumumab or hyaluronidase.
Tell your doctor about any of the following:
- Heart problems (if you're being treated for light-chain amyloidosis);
- Breathing problems
- Hepatitis B
- Herpes zoster (shingles).
Daratumumab or hyaluronidase can harm an unborn child. Prevent pregnancy by using effective birth control while taking this medication and for 3 months following your last dose. Inform your doctor immediately if you fall pregnant. Daratumumab or hyaluronidase may be used in conjunction with lenalidomide. Lenalidomide is only effective if both men and women use birth control. Lenalidomide can cause serious birth defects and even death in a newborn if taken by either the mother or father at the time conception occurs or during pregnancy. Follow all instructions regarding birth control when using Daratumumab or hyaluronidase with other medications. Do not breastfeed. Consult your healthcare provider for advice on how to feed a baby when using daratumumab or hyaluronidase.
How to take Daratumumab and hyaluronidase?
Daratumumab hyaluronidase is injected into the skin. This injection will be given by a healthcare provider. Other medications may be prescribed to prevent allergic reactions or serious side effects. Continue to use these medications as prescribed by your doctor. The dose of daratumumab/hyaluronidase will be given to you every 1–4 weeks until your body stops responding to the medication. Your doctor will decide how long you should be treated with daratumumab and hyaluronidase and how frequently you should receive injections. The injection should be given under your stomach skin. You should not give any other injections, such as Insul, in the same area where you gave your last daratumumab hyaluronidase. The schedules for other medications may differ from the schedules for daratumumab or hyaluronidase when used together. Your next dose could be delayed, depending on the results of your medical tests. Daratumumab, hyaluronidase, and other medications can cause long-lasting effects on the body and may affect certain medical tests up to six months after your last dosage. Be sure to tell any doctor who treats you that you have been treated with this medication. Daratumumab combined with hyaluronidase may cause the virus to become more active or worse if you have ever had hepatitis B. This medicine may require frequent liver function testing while you are taking it and for several months afterwards.
Details on dosage
Adult dose for multiple myeloma:
Subcutaneous administration of 1800 mg/30,000 units (300 mg daratumumab, 30,000 units hyaluronidase)
Duration of treatment:
Use as a monotherapy or combined with dexamethasone or lenalidomide.
Weeks 1 to 8: Weekly (8 doses).
Every 2 weeks from Weeks 9 to 24,
Every 4 weeks from week 25 until the disease progresses
Comments:
Consult the product information from the manufacturer for dosage as part of combination therapy.
Premedicate the patient with Acetaminophen from 650 mg to 1000 mg, Diphenhydramine between 25 and 50 mg (or an equivalent dose) orally or intravenously, as well as a corticosteroid of intermediate or long-acting such as Methylprednisolone (or 100 mg equivalent) either orally or intravenously. After the second dose, consider reducing methylprednisolone's dose to 60mg (or its equivalent).
Post-medicate patients with 20 mg methylprednisolone (or equivalent doses of intermediate- or longer-acting corticosteroids) orally, starting the next day.
Consult the prescribing information of the manufacturer for pre-medication or post-medication advice when combined with other therapies.
Uses:
Adult patients with multiple myeloma can be treated by:
as a monotherapy in patients who have failed at least three previous lines of treatment, including a proteasome inhibitor (PI) or an immunomodulatory drug.
Combination of lenalidomide with dexamethasone for newly diagnosed patients ineligible to receive an autologous stem-cell transplant and patients with relapsed and refractory myeloma after at least one previous therapy
Combination of Bortezomib with Melphalan or Prednisone for newly diagnosed patients ineligible to receive autologous stem cell transplants
Combination with dexamethasone and bortezomib in patients who received at least one previous therapy
What happens if I miss the dose?
If you missed your appointment for the daratumumab/hyaluronidase, call your doctor to get instructions. Do not miss any of the other medications you take in conjunction with Daratumumab or hyaluronidase.
What happens if I overdose?
Overdoses are unlikely because daratumumab is administered by a healthcare provider in a medical environment.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Interaction with other drug
Daratumumab or hyaluronidase may be affected by other drugs, such as vitamins and herbal remedies. Inform your doctor of all the medicines you are currently taking and those that you will begin or stop using.
