Applies to teclistamab: subcutaneous solution.

Serious side effects of Teclistamab

Along with its needed effects, teclistamab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking teclistamab:

More common

• Absence of or decrease in body movement
• agitation
• back pain
• being forgetful
• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody eye
• bloody nose
• bloody or cloudy urine
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• body aches or pain
• chest pain, discomfort, or tightness
• chills
• collection of blood under the skin
• coma
• confusion
• confusion as to time, place, or person
• cough
• coughing up blood
• decreased urine output
• deep, dark purple bruise
• depression
• difficult, burning, or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dryness or soreness of the throat
• ear congestion
• fever
• frequent urge to urinate
• hallucinations
• headache
• hoarseness
• holding false beliefs that cannot be changed by fact
• hostility
• increased menstrual flow or vaginal bleeding
• irritability
• itching, pain, redness, or swelling
• loss of voice
• lower back or side pain
• mood or mental changes
• muscle aches, stiffness, spasm, tightness, or twitching
• nausea and vomiting
• nerve pain
• nervousness
• nosebleeds
• pain in the lower back, bottom, hips, or upper leg
• pain or tenderness around the eyes and cheekbones
• paralysis
• pounding in the ears
• pounding or rapid pulse
• problems with speech or speaking
• prolonged bleeding from cuts
• rapid or irregular heartbeat
• red or dark brown urine
• red or black, tarry stools
• seizures
• shakiness in the legs, arms, hands, feet
• slow or fast heartbeat
• sneezing
• sore throat
• stiff neck
• stuffy or runny nose
• stupor
• sweating
• swelling of the face, ankles, or hands
• tender, swollen glands in the neck
• tingling of the hands or feet
• trembling and shaking of the hands
• trouble breathing
• trouble in swallowing
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual excitement, nervousness, or restlessness
• unusual weight gain or loss
• voice changes
• weight gain

Incidence not known

• Burning, throbbing, or stabbing pain
• clay colored stools
• decreased appetite
• double vision
• jerking movements
• loss of appetite
• pale skin
• stomach pain or tenderness
• trouble speaking
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising

Other side effects of Teclistamab

Some side effects of teclistamab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• constipation
• diarrhea
• difficulty in moving
• joint pain
• lack or loss of strength
• muscle or bone pain

For Healthcare Professionals

Applies to teclistamab: subcutaneous solution.

Cardiovascular

-Hemorrhage includes conjunctival hemorrhage, epistaxis, hematoma, hematuria, hemoperitoneum, hemorrhoidal hemorrhage, lower gastrointestinal hemorrhage, melena, mouth hemorrhage, and subdural hematoma.

-Hypertension includes both essential hypertension and hypertension.

-Cardiac arrhythmias include atrial flutter, cardiac arrest, sinus bradycardia, tachycardia, sinus tachycardia, supraventricular tachycardia, and ventricular tachycardia.^[Ref]

Very common (10% or more): Hypotension (18%), hemorrhage (12%), hypertension (12%), cardiac arrhythmia (16%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (25%), diarrhea (21%), constipation (18%), vomiting (12%)

Uncommon (0.1% to 1%): Hemoperitoneum^[Ref]

General

-The most common adverse reactions with a frequency of 20% or more were pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.

-The most common life-threatening and fatal laboratory abnormalities with a frequency of 20% or more were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.^[Ref]

Genitourinary

-Urinary tract infection includes cystitis, cystitis Escherichia, cystitis Klebsiella, Escherichia urinary tract infection, urinary tract infection and bacterial urinary tract infection.^[Ref]

Very common (10% or more): Urinary tract infection (11%)^[Ref]

Hematologic

Very common (10% or more): Decreased lymphocyte count (92%), decreased white blood cell (86%), decreased neutrophil count (84%), decreased platelet count (71%), decreased hemoglobin (67%)

Frequency not reported: Neutropenia^[Ref]

-Febrile neutropenia occurred in less than 10% patients using this drug.^[Ref]

Hepatic

Frequency not reported: Hepatic failure^[Ref]

Immunologic

Very common (10% or more): Cytokine release syndrome (72%), hypogammaglobulinemia (11%)^[Ref]

-Hypogammaglobulinemia includes both hypogammaglobulinemia and hypoglobulinemia.^[Ref]

Local

Very common (10% or more): Pain (15%), injection site reaction (37%)^[Ref]

-Injection site reaction includes application site erythema, injection site bruising, injection site cellulitis, injection site discomfort, injection site erythema, injection site hematoma, injection site induration, injection site inflammation, injection site edema, injection site pruritus, injection site rash, injection site reaction, and injection site swelling.

-Pain includes ear pain, flank pain, groin pain, oropharyngeal pain, pain in jaw, toothache, and tumor pain.^[Ref]

Musculoskeletal

Musculoskeletal pain includes arthralgia, back pain, muscle discomfort, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, and pain in the extremities.^[Ref]

Very common (10% or more): Musculoskeletal pain (44%), bone pain (16%)^[Ref]

Metabolic

Very common (10% or more): Edema (13%), decreased appetite (11%)

Frequency not reported: Hypercalcemia^[Ref]

Edema includes peripheral edema and swelling, facial edema, fluid overload, and fluid retention.^[Ref]

Other

-Viral infections including adenovirus, hepatitis B virus (HBV), cytomegalovirus (CMV), varicella zoster virus (VZV), and herpes simplex virus (HSV) have been reported in less than 10% of patients using this drug.

-Fatigue includes asthenia and fatigue.^[Ref]

Very common (10% or more): Decreased albumin (68%), increased alkaline phosphatase (42%), decreased phosphorus (38%), increased Gamma-glutamyl transferase (37%), decreased sodium (35%), increased aspartate aminotransferase (34%), decreased calcium (31%), increased creatinine (30%), chills (16%), fatigue (33%), pyrexia (76%)

Common (1% to 10%): Sepsis, general physical health deterioration

Frequency not reported: Viral infections^[Ref]

Renal

Acute kidney injury includes both acute kidney injury and renal impairment.^[Ref]

Very common (10% or more): Acute kidney injury (11%)

Uncommon (0.1% to 1%): Acute renal failure^[Ref]

Respiratory

-Pneumonia includes COVID-19 pneumonia, enterobacter pneumonia, lower respiratory tract infection, metapneumovirus pneumonia, pneumocystis jirovecii pneumonia, pneumonia adenoviral, pneumonia klebsiella, pneumonia moraxella, pneumonia pneumococcal, pneumonia pseudomonal, pneumonia respiratory syncytial viral, pneumonia staphylococcal, and pneumonia viral.

-Upper respiratory tract infections include bronchitis, influenza like illness, nasopharyngitis, pharyngitis, respiratory tract infection, bacterial respiratory tract infection, rhinitis, rhinovirus infection, sinusitis, tracheitis, upper respiratory tract infection, and viral upper respiratory tract infection.

-Cough includes allergic cough, productive cough, and upper-airway cough syndrome.^[Ref]

Very common (10% or more): Pneumonia 24%, upper respiratory tract infection (26%), hypoxia (18%), cough (15%)

Common (1% to 10%): COVID-19^[Ref]

Nervous system

Very common (10% or more): Headache (25%), motor dysfunction (16%), sensory neuropathy (15%), encephalopathy (13%)

Frequency not reported: Immune effector cell-associated neurotoxicity syndrome (ICANS), seizure, Guillain-Barré syndrome^[Ref]

-Motor dysfunction includes cogwheel rigidity, dysgraphia, dysphonia, gait disturbance, hypokinesia, muscle rigidity, muscle spasms, muscular weakness, peroneal nerve palsy, psychomotor hyperactivity, tremor and sixth nerve paralysis.

-Sensory neuropathy includes dysesthesia, hypoesthesia, hypoesthesia oral, neuralgia, paresthesia, paresthesia oral, peripheral sensory neuropathy, sciatica and vestibular neuronitis.

-Encephalopathy includes agitation, apathy, aphasia, confusional state, delirium, depressed level of consciousness, disorientation, dyscalculia, hallucination, lethargy, memory impairment, mental status changes and somnolence.^[Ref]