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Arzerra

"The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).

 

CLL is a blood and bone ma"...

Arzerra

Arzerra

Arzerra Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Arzerra (ofatumumab) Injection is a monoclonal antibody used in to treat chronic lymphocytic leukemia. It is usually given after other medications have been tried without successful treatment of symptoms. Common side effects include nausea, vomiting, diarrhea, tiredness, swelling of hands/ankles/feet, or trouble sleeping.

The recommended dosage and schedule of Arzerra is 12 doses administered as follows: 300 mg initial dose (Dose 1), followed 1 week later by 2,000 mg weekly for 7 doses (Doses 2 through 8), followed 4 weeks later by 2,000 mg every 4 weeks for 4 doses (Doses 9 through 12). Arzerra may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Arzerra should be used only if prescribed. It is unknown if this drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Arzerra (ofatumumab) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Arzerra in Detail - Patient Information: Side Effects

Some people receiving a ofatumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, confused, itchy, tingly, or have chest pain, jaw or arm pain, back pain, stomach pain, wheezing, chest tightness, or trouble breathing. These reactions can occur during the injection or within 24 hours afterward..

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • confusion, weakness on one side of the body, loss of balance or coordination; or
  • severe constipation.

Less serious side effects may include:

  • mild nausea, diarrhea;
  • swelling in your hands or feet.
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • tired feeling; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Arzerra (Ofatumumab Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Arzerra Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning and How to Use section.

Nausea, vomiting, diarrhea, tiredness, swelling of hands/ankles/feet, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Your doctor will order blood tests to check for this side effect. It is important to keep all medical/lab test appointments. Tell your doctor immediately if you develop any of the following symptoms: easy bruising/bleeding, pale skin, unusual tiredness, signs of infection (such as fever, chills, cough, persistent sore throat).

Ofatumumab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Also, your doctor may prescribe an additional medication. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), pink/bloody urine, change in the amount of urine, painful urination, muscle spasms/weakness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Arzerra (Ofatumumab Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Arzerra FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

Previously Untreated CLL

The most common adverse reactions ( ≥ 10%) were infusion reactions and neutropenia (Table 3).

Refractory CLL

The most common adverse reactions ( ≥ 10%) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections (Table 5). The most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexia. Infections were the most common adverse reactions leading to drug discontinuation.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Previously Untreated CLL

The safety of ARZERRA was evaluated in an open-label, parallelarm, randomized trial (Study 1) in 444 patients with previously untreated CLL. Patients were randomized to receive either ARZERRA as an intravenous infusion every 28 days in combination with chlorambucil (n = 217) or chlorambucil as a single agent (n = 227). In both arms, patients received chlorambucil 10 mg/m orally on Days 1 to 7 every 28 days. The infusion schedule for ARZERRA was 300 mg administered on Cycle 1 Day 1, 1,000 mg administered on Cycle 1 Day 8, and 1,000 mg administered on Day 1 of subsequent 28-day cycles. The median number of cycles of ARZERRA completed was 6.

The data described in Table 3 include relevant adverse reactions occurring up to 60 days after the last dose of study medication; Table 4 includes relevant hematologic laboratory abnormalities.

Table 3: Adverse Reactions With ≥ 5% Incidence in Patients Receiving ARZERRA Plus Chlorambucil and Also ≥ 2% More Than Patients Receiving Chlorambucil

Adverse Reactions ARZERRA Plus Chlorambucil (N = 217) Chlorambucil (N = 227)
All Grades
%
Grade ≥ 3
%
All Grades
%
Grade ≥ 3
%
Infusion reactionsa 67 10 0 0
Neutropenia 27 26 18 14
Asthenia 8 < 1 5 0
Headache 7 < 1 3 0
Leukopenia 6 3 2 < 1
Herpes simplexb 6 0 4 < 1
Lower respiratory tract infection 5 1 3 < 1
Arthralgia 5 < 1 3 0
Upper abdominal pain 5 0 3 0
a Includes events which occurred on the day of an infusion or within 24 hours of the end of an infusion and resulted in an interruption or discontinuation of treatment. Infusion reactions may include, but are not limited to, chills, dyspnea, flushing, hypotension, nausea, pain, pruritus, pyrexia, rash, and urticaria.
b Includes oral herpes, herpes, herpes virus infection, genital herpes, and herpes simplex.

Table 4: Post-baseline Hematologic Laboratory Abnormalities Occurring With ≥ 5% Incidence in Patients Receiving ARZERRA Plus Chlorambucil and Also ≥ 2% More Than Patients Receiving Chlorambucil

ARZERRA plus Chlorambucil
(N = 217)
Chlorambucil
(N = 227)
All Grades
%
Grade ≥ 3
%
All Grades
%
Grade ≥ 3
%
Leukopenia 67 23 28 4
Neutropenia 66 29 56 24
Lymphopenia 52 29 20 7

Infusion Reactions

Overall, 67% of patients who received ARZERRA in combination with chlorambucil experienced one or more symptoms of infusion reactions (10% were Grade 3 or greater; none were fatal). Infusion reactions that were either Grade 3 or greater, serious, or led to treatment interruption or discontinuation occurred most frequently during Cycle 1 (56% on Day 1 [6% were Grade 3 or greater] and 23% on Day 8 [3% were Grade 3 or greater]) and decreased with subsequent infusions. Infusion reactions led to discontinuation of treatment in 3% of patients. Serious adverse events of infusion reactions occurred in 2% of patients.

Neutropenia

Overall, 3% of patients had neutropenia as a serious adverse event, reported up to 60 days after the last dose. One patient died with neutropenic sepsis and agranulocytosis. Prolonged neutropenia occurred in 6% of patients receiving ARZERRA in combination with chlorambucil compared with 4% of patients receiving chlorambucil. Late-onset neutropenia occurred in 6% of patients receiving ARZERRA in combination with chlorambucil compared with 1% of patients receiving chlorambucil alone.

Refractory CLL

The safety of monotherapy with ARZERRA was evaluated in 181 patients with relapsed or refractory CLL in 2 open-label, non-randomized, single-arm studies. In these studies, ARZERRA was administered at 2,000 mg beginning with the second dose for 11 doses (Study 2 [n = 154]) or 3 doses (Study 3 [n = 27]).

The data described in Table 5 and other sections below are derived from 154 patients in Study 2. All patients received 2,000 mg weekly from the second dose onward. Ninety percent of patients received at least 8 infusions of ARZERRA and 55% received all 12 infusions. The median age was 63 years (range: 41 to 86 years), 72% were male, and 97% were white.

Table 5: Incidence of All Adverse Reactions Occurring in ≥ 5% of Patients and in the Fludarabine- and Alemtuzumab-refractory Subset

Total Population
(N =154)
Fludarabine- and Alemtuzumab- refractory
(N =59)
Adverse Reaction
All Grades
%
Grade ≥ 3
%
All Grades
%
Grade ≥ 3
%
Pneumoniaa 23 14 25 15
Pyrexia 20 3 25 5
Cough 19 0 19 0
Diarrhea 18 0 19 0
Anemia 16 5 17 8
Fatigue 15 0 15 0
Dyspnea 14 2 19 5
Rashb 14 < 1 17 2
Bronchitis 11 < 1 19 2
Nausea 11 0 12 0
Upper respiratory tract infection 11 0 3 0
Edema peripheral 9 < 1 8 2
Back pain 8 1 12 2
Chills 8 0 10 0
Nasopharyngitis 8 0 8 0
Sepsisc 8 8 10 10
Urticaria 8 0 5 0
Insomnia 7 0 10 0
Headache 6 0 7 0
Herpes zoster 6 1 7 2
Hyperhidrosis 5 0 5 0
Hypertension 5 0 8 0
Hypotension 5 0 3 0
Muscle spasms 5 0 3 0
Sinusitis 5 2 3 2
Tachycardia 5 < 1 7 2
a Includes pneumonia, lung infection, lobar pneumonia, and bronchopneumonia.
b Includes rash, rash macular, and rash vesicular.
c Includes sepsis, neutropenic sepsis, bacteremia, and septic shock.

Infusion Reactions

Infusion reactions occurred in 44% of patients on the day of the first infusion (300 mg), 29% on the day of the second infusion (2,000 mg), and less frequently during subsequent infusions.

Infections

A total of 108 patients (70%) experienced bacterial, viral, or fungal infections. A total of 45 patients (29%) experienced Grade 3 or greater infections, of which 19 (12%) were fatal. The proportion of fatal infections in the fludarabine- and alemtuzumab-refractory group was 17%.

Neutropenia

Of 108 patients with normal neutrophil counts at baseline, 45 (42%) developed Grade 3 or greater neutropenia. Nineteen (18%) developed Grade 4 neutropenia. Some patients experienced new onset Grade 4 neutropenia > 2 weeks in duration.

Immunogenicity

There is a potential for immunogenicity with therapeutic proteins such as ofatumumab. Serum samples from more than 300 patients with CLL were tested during and after treatment for antibodies to ARZERRA. There was no formation of anti-ofatumumab antibodies in patients with CLL after treatment with ofatumumab.

Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to ARZERRA with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ARZERRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infusion-related Cardiac Events: Cardiac arrest.

Mucocutaneous Reactions: Stevens-Johnson syndrome, porphyria cutanea tarda.

Read the entire FDA prescribing information for Arzerra (Ofatumumab Injection) »

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Arzerra - User Reviews

Arzerra User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Arzerra sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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