Erlotinib Stada Uses

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What is Erlotinib Stada?

Erlotinib Stada is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body.

Erlotinib Stada is used to treat non-small cell lung cancer or pancreatic cancer that has spread to other parts of the body (metastatic).

Erlotinib Stada is usually given after other cancer medicines have been tried without success.

Erlotinib Stada may also be used for purposes not listed in this medication guide.

Erlotinib Stada indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Non-Small Cell Lung Cancer (NSCLC)

Erlotinib Stada is indicated for:

The first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
The maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
The treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

Limitations of use:

Erlotinib Stada is not recommended for use in combination with platinum-based chemotherapy.
Safety and efficacy of Erlotinib Stada have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution.

Pancreatic Cancer

Erlotinib Stada in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

How should I use Erlotinib Stada?

Use Erlotinib Stada as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Erlotinib Stada.

Uses of Erlotinib Stada in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Erlotinib Stada is used to treat lung and pancreatic cancer. It works by slowing or stopping the growth of cancer cells.

How to use Erlotinib Stada

Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal) as directed by your doctor, usually once daily.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Medications that lower stomach acid (such as antacids, H2 blockers including ranitidine) may prevent Erlotinib Stada from working. Ask your doctor or pharmacist how to use these medications safely with Erlotinib Stada.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Erlotinib Stada description

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Erlotinib Stada hydrochloride (trade name Erlotinib Stada, Genentech/OSIP, originally coded as OSI-774) is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. Similar to gefitinib, Erlotinib Stada specifically targets the epidermal growth factor receptor (EGFR) tyrosine kinase. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor. Erlotinib Stada has recently been shown to be a potent inhibitor of JAK2V617F activity. JAK2V617F is a mutant of tyrosine kinase JAK2, is found in most patients with polycythemia vera (PV) and a substantial proportion of patients with idiopathic myelofibrosis or essential thrombocythemia. The study suggests that Erlotinib Stada may be used for treatment of JAK2V617F-positive PV and other myeloproliferative disorders.

Erlotinib Stada dosage

Erlotinib Stada Dosage

Generic name: Erlotinib Stada HYDROCHLORIDE 25mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Patient Selection

Select patients for the first-line treatment of metastatic NSCLC with Erlotinib Stada based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor ​or plasma specimens. ​If these mutations are not detected in a plasma specimen, test tumor tissue if available. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dose – NSCLC

The recommended daily dose of Erlotinib Stada for NSCLC is 150 mg taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.

Recommended Dose – Pancreatic Cancer

The recommended daily dose of Erlotinib Stada for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. Take Erlotinib Stada on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.

Dose Modifications

Discontinue Erlotinib Stada for:

Interstitial Lung Disease (ILD).
Severe hepatic toxicity that does not improve significantly or resolve within three weeks.
Gastrointestinal perforation.
Severe bullous, blistering or exfoliating skin conditions.
Corneal perforation or severe ulceration.

Withhold Erlotinib Stada:

During diagnostic evaluation for possible ILD.
For severe (CTCAE grade 3 to 4) renal toxicity, and consider discontinuation of Erlotinib Stada.
In patients without pre-existing hepatic impairment for total bilirubin levels greater than 3 times the upper limit of normal or transaminases greater than 5 times the upper limit of normal, and consider discontinuation of Erlotinib Stada.
In patients with pre-existing hepatic impairment or biliary obstruction for doubling of bilirubin or tripling of transaminases values over baseline and consider discontinuation of Erlotinib Stada.
For persistent severe diarrhea not responsive to medical management (e.g., loperamide).
For severe rash not responsive to medical management.
For keratitis of (NCI-CTC version 4.0) grade 3-4 or for grade 2 lasting more than 2 weeks.
For acute/worsening ocular disorders such as eye pain, and consider discontinuation of Erlotinib Stada.

Reduce Erlotinib Stada by 50 mg decrements:

If severe reactions occur with concomitant use of strong CYP3A4 inhibitors [such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, or grapefruit or grapefruit juice] or when using concomitantly with an inhibitor of both CYP3A4 and CYP1A2 (e.g., ciprofloxacin). Avoid concomitant use if possible.
When restarting therapy following withholding treatment for a dose-limiting toxicity that has resolved to baseline or grade ≤ 1.

Increase Erlotinib Stada by 50 mg increments as tolerated for:

Concomitant use with CYP3A4 inducers, such as rifampin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, or St. John’s Wort. Increase doses by 50 mg increments at 2 week intervals to a maximum of 450 mg. Avoid concomitant use, if possible.
​Concurrent cigarette smoking in patients with pancreatic cancer or EGFR mutation positive NSCLC. Increase by 50 mg increments at 2 week intervals to a maximum of 300 mg. Immediately reduce the dose of Erlotinib Stada to the recommended dose (150 mg or 100 mg daily) upon cessation of smoking ​.

Drugs Affecting Gastric pH

Avoid concomitant use of Erlotinib Stada with proton pump inhibitors if possible. Separation of doses may not eliminate the interaction since proton pump inhibitors affect the pH of the upper GI tract for an extended period.
If treatment with an H2-receptor antagonist such as ranitidine is required, Erlotinib Stada must be taken 10 hours after the H2-receptor antagonist dosing and at least 2 hours before the next dose of the H2-receptor antagonist.
Although the effect of antacids on Erlotinib Stada pharmacokinetics has not been evaluated, the antacid dose and the Erlotinib Stada dose should be separated by several hours, if an antacid is necessary.

More about Erlotinib Stada (Erlotinib Stada)

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Erlotinib Stada interactions

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What other drugs will affect Erlotinib Stada?

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Erlotinib Stada is metabolized in the liver by the hepatic cytochromes in humans, primarily CYP3A4 and to a lesser extent by CYP1A2 and the pulmonary isoform CYP1A1. Potential interactions may occur with drugs which are metabolized by, or are inhibitors or inducers of these enzymes.

Potent inhibitors of CYP3A4 activity decrease Erlotinib Stada metabolism and increase Erlotinib Stada plasma concentrations. Inhibition of CYP3A4 metabolism by ketoconazole (200 mg orally twice daily for 5 days) resulted in increased exposure to Erlotinib Stada (86% in median Erlotinib Stada exposure AUC) and a 69% increase in maximum plasma concentration (Cmax) when compared to Erlotinib Stada alone. When Erlotinib Stada was co-administered with ciprofloxacin, an inhibitor of both CYP3A4 and CYP1A2, the Erlotinib Stada exposure (AUC) and Cmax increased by 39% and 17%, respectively. Therefore, caution should be used when administering Erlotinib Stada with potent CYP3A4 or combined CYP3A4/CYP1A2 inhibitors. In these situations, the dose of Erlotinib Stada should be reduced if toxicity is observed.

Potent inducers of CYP3A4 activity increase Erlotinib Stada metabolism and significantly decrease Erlotinib Stada plasma concentrations. Induction of CYP3A4 metabolism by rifampicin (600 mg orally everday for 7 days) resulted in a 69% decrease in the median Erlotinib Stada AUC, following Erlotinib Stada 150 mg, as compared to Erlotinib Stada alone.

Pre-treatment and co-administration of rifampicin with a single Erlotinib Stada 450 mg resulted in a mean Erlotinib Stada exposure (AUC) of 57.5% of that after a single 150-mg Erlotinib Stada dose in the absence of rifampicin treatment. Alternative treatments lacking potent CYP3A4 inducing activity should be considered when possible. For patients who require concomitant treatment with Erlotinib Stada and a potent CYP3A4 inducer eg, rifampicin, an increase in dose to 300 mg should be considered while their safety is closely monitored and if well tolerated for >2 weeks, further increase to 450 mg could be considered with close safety monitoring. Higher doses have not been studied in this setting.

Pre-treatment or co-administration of Erlotinib Stada did not alter the clearance of the prototypical CYP3A4 substrates midazolam and erythromycin. Significant interactions with the clearance of other CYP3A4 substrates are therefore unlikely.

Oral availability of midazolam did appear to decrease by up to 24%, which was however not attributed to effects on CYP3A4 activity.

The solubility of Erlotinib Stada is pH dependent. Erlotinib Stada solubility decreases as pH increases. Drugs that alter the pH of the upper gastrointestinal (GI) tract may alter the solubility of Erlotinib Stada and hence its bioavailability. Co-administration of Erlotinib Stada with omeprazole, a proton pump inhibitor, decreased the Erlotinib Stada exposure (AUC) and Cmax by 46% and 61%, respectively. There was no change to Tmax or half-life (t½). Concomitant administration of Erlotinib Stada with ranitidine 300 mg, an H2-receptor antagonist, decreased Erlotinib Stada exposure (AUC) and Cmax by 33% and 54%, respectively. Therefore, co-administration of drugs reducing gastric acid production with Erlotinib Stada should be avoided where possible. Increasing the dose of Erlotinib Stada when co-administered with such agents is not likely to compensate for this loss of exposure. However, when Erlotinib Stada was dosed in a staggered manner 2 hrs before or 10 hrs after ranitidine 150 mg twice daily, Erlotinib Stada exposure (AUC) and Cmax decreased only by 15% and 17%, respectively. If patients need to be treated with such drugs, then an H2-receptor antagonist eg, ranitidine should be considered and used in a staggered manner. Erlotinib Stada must be taken at least 2 hrs before or 10 hrs after the H2-receptor antagonist dosing.

Interaction with coumarin-derived anticoagulants, including warfarin, leading to increased international normalized ratio (INR) and bleeding events, which in some cases were fatal have been reported in patients receiving Erlotinib Stada. Patients taking coumarin-derived anticoagulants should be monitored regularly for any changes in prothrombin time or INR.

The combination of Erlotinib Stada and a statin may increase the potential for statin-induced myopathy, including rhabdomyolysis, which was observed rarely.

Smokers should be advised to stop smoking as cigarette smoking, which is known to induce CYP1A1 and CYP1A2, has been shown to reduce Erlotinib Stada exposure by 50-60%.

In a phase Ib study, there were no significant effects of gemcitabine on the pharmacokinetics of Erlotinib Stada nor were there significant effects of Erlotinib Stada on the pharmacokinetics of gemcitabine.

Erlotinib Stada side effects

See also:
What are the possible side effects of Erlotinib Stada?

Non-Small Cell Lung Cancer (Erlotinib Stada Administered as Single Agent in Study BR.21): In 1 randomized double-blind study BR.21 conducted in 17 countries, 731 patients with locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen were randomized 2:1 to receive Erlotinib Stada 150 mg or placebo. Study drug was taken orally once daily until disease progression or unacceptable toxicity.

Rash (75%) and diarrhea (54%) were the most frequent adverse events regardless of causality. Most were grade 1 or grade 2 in severity and manageable without intervention. Grade 3/4 rash and diarrhea occurred in 9% and 6%, respectively, in patients treated with Erlotinib Stada and each resulted in study discontinuation in 1% of patients. Dose reduction for rash and diarrhea was needed in 6% and 1% of patients, respectively. In study BR.21 the median time to onset of rash was 8 days and the median time to onset of diarrhea was 12 days.

Adverse events occurring more frequently (≥3%) in patients treated with Erlotinib Stada than in the placebo arm in the pivotal study BR.21 and in at least 10% of patients in the Erlotinib Stada arm, are summarized by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade in Table 3. Listed events are assessed by the sponsor as being adverse drug reactions attributed to Erlotinib Stada therapy.

Pancreatic Cancer (Erlotinib Stada Administered concomittantly with Gemcitabine in Study PA.3): The most frequent adverse reactions in pivotal study PA.3 in pancreatic cancer patients receiving Erlotinib Stada 100 mg plus gemcitabine were fatigue, rash and diarrhea. In the Erlotinib Stada plus gemcitabine arm, Grade 3/4 rash and diarrhea were each reported in 5% of patients. The median time to onset of rash and diarrhea was 10 and 15 days, respectively. Rash and diarrhea each resulted in dose reductions in 2% of patients and resulted in study discontinuation in up to 1% of patients receiving Erlotinib Stada plus gemcitabine.

The Erlotinib Stada 150 mg plus gemcitabine cohort (23 patients) was associated with a higher rate of certain class-specific adverse reactions including rash and required more frequent dose reduction or interruption.

Adverse events occurring more frequently (≥3%) in Erlotinib Stada 100 mg plus gemcitabine-treated patients than in the placebo plus gemcitabine group in the pivotal study PA.3 and in at least 10% of patients in the Erlotinib Stada 100 mg plus gemcitabine group, are summarized by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 4. Listed events are assessed by the sponsor as being adverse drug reactions attributed to Erlotinib Stada therapy.

Other Observations (Based on Data from All Clinical Studies): Safety evaluation of Erlotinib Stada is based on the data from >800 patients treated with at least one Erlotinib Stada 150 mg monotherapy and >300 patients who received Erlotinib Stada 100 mg or 150 mg in combination with gemcitabine.

The following adverse reactions have been observed in patients who received Erlotinib Stada 150 mg as monotherapy or 100 mg or 150 mg in combination with gemcitabine.

The following terms are used to rank the adverse reactions by frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000) including isolated reports.

Very common adverse reactions (ADRs) are presented in Tables 3 and 4, ADRs in other frequency categories are summarized as follows.

Gastrointestinal Disorders: Gastrointestinal perforations have been reported uncommonly (<1% of patients) with Erlotinib Stada treatment, in some cases with a fatal outcome.

Cases of gastrointestinal bleeding have been reported commonly (including some fatalities), some associated with concomitant warfarin administration, and some with concomitant NSAIDs.

Hepatobiliary Disorders: Liver function test abnormalities (including raised ALT, AST, bilirubin) have been observed commonly in clinical trials of Erlotinib Stada. In study PA.3, these occurred very commonly. They were mainly mild or moderate in severity, transient in nature or associated with liver metastases. Rare cases of hepatic failure (including fatalities) have been reported during use of Erlotinib Stada. Confounding factors have included preexisting liver disease or concomitant hepatotoxic medications.

Eye Disorders: Corneal ulcerations or perforations have been reported very rarely in patients receiving Erlotinib Stada treatment. Keratitis and conjunctivitis have been reported commonly with Erlotinib Stada.

Abnormal eyelash growth, including in-growing eyelashes, excessive growth and thickening of the eyelashes have been reported.

Respiratory, Thoracic and Mediastinal Disorders: There have been uncommon reports of serious ILD-like events, (including fatalities), in patients receiving Erlotinib Stada for treatment of NSCLC and other advanced solid tumours. Cases of epistaxis have also been reported commonly in both the NSCLC and the pancreatic cancer trials.

Skin and Subcutaneous Tissue Disorders: Rash has been reported very commonly in patients receiving Erlotinib Stada and in general, manifests as a mild or moderate erythematous and papulopustular rash, which may occur or worsen in sun-exposed areas. For patients who are exposed to sun, protective clothing and/or use of sun screen (eg, mineral-containing) may be advisable. Acne, dermatitis acneiform and folliculitis have been observed commonly, most of these events were mild or moderate and non-serious. Skin fissures, mostly non-serious, were reported commonly and in the majority of cases were associated with rash and dry skin. Other mild skin reactions eg, hyperpigmentation have been observed uncommonly (<1% of patients).

Bullous, blistering and exfoliative skin conditions have been reported, including very rare cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal.

Hair and nail changes, mostly non-serious, were reported in clinical trials, eg, paronychia was reported commonly and hirsutism, eyelash/eyebrow changes and brittle and loose nails were reported uncommonly.

Post-Marketing: Skin and Subcutaneous Tissue Disorders: Hair and nail changes, mostly non-serious, were reported uncommonly from post-marketing surveillance eg, hirsutism, eyelash/eyebrow changes, paronychia and brittle and loose nails.

Cases of uveitis have been reported in post-marketing surveillance.

Erlotinib Stada contraindications

See also:
What is the most important information I should know about Erlotinib Stada?

Do not take Erlotinib Stada if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 2 weeks after your treatment ends.

Before taking Erlotinib Stada, tell your doctor if you have lung problems (other than lung cancer), kidney or liver disease, if you are dehydrated, or if you smoke.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine how long to treat you with Erlotinib Stada. Visit your doctor regularly.

Avoid exposure to sunlight or tanning beds. Erlotinib Stada can cause skin rash, dryness, or other irritation. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Avoid using skin products that can cause dryness or irritation.

Stop taking Erlotinib Stada and call your doctor at once if you have new or worsening lung problems (chest pain, dry cough with fever, wheezing, feeling short of breath), chest pain spreading to the arm or shoulder, sudden numbness or weakness, eye pain or irritation, rapid weight gain, urinating less than usual or not at all, severe or ongoing diarrhea or vomiting, coughing up blood, black or bloody stools, pale skin, easy bruising or bleeding, mouth sores, or a severe skin rash.

There are many other drugs that can interact with Erlotinib Stada. Tell your doctor about all medications you use. Keep a list of all your medicines and show it to any healthcare provider who treats you.



Active ingredient matches for Erlotinib Stada:

Erlotinib in Sweden.


List of Erlotinib Stada substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
ERLOTIREL 150MG TABLET 1 strip / 30 tablets each (Reliance Life Sciences)$ 142.91
INNOTINIB tab 150 mg x 10's (Innova)$ 158.71
150 mg x 10's (RPG LS)$ 174.60
Lortinib 150mg TAB / 10 (RPG LS)$ 174.60
LORTINIB 150MG TABLET 1 strip / 10 tablets each (RPG LS)$ 177.14
LORTINIB tab 150 mg x 10's (RPG LS)$ 174.60
Lortinib 150mg TAB / 10 (RPG LS)$ 174.60
Lortinib 150mg Tablet (RPG LS)$ 17.71
PMS-erlotinib tablet 150 mg (Pharmascience Inc (Canada))
PMS-erlotinib tablet 100 mg (Pharmascience Inc (Canada))
Tablet, Film-Coated; Oral; Erlotinib Hydrochloride 25 mg (Roche)
Tablet, Film-Coated; Oral; Erlotinib Hydrochloride 50 mg (Roche)
Tablet, Film-Coated; Oral; Erlotinib Hydrochloride 100 mg (Roche)
Tablet, Film-Coated; Oral; Erlotinib Hydrochloride 150 mg (Roche)
Tablet; Oral; Erlotinib Hydrochloride 25 mg (Roche)
Tablet; Oral; Erlotinib Hydrochloride 100 mg (Roche)
Tablet; Oral; Erlotinib Hydrochloride 150 mg (Roche)
150 mg x 10's (Roche)
Tarceva 25 mg x 30'S (Roche)
Tarceva 100 mg x 30'S (Roche)$ 1666.67
Tarceva 150 mg x 30'S (Roche)$ 2488.89
30 tablet in 1 bottle (Roche)
Tarceva 25 mg x 3 x 10's (Roche)$ 635.35
Tarceva 100 mg x 3 x 10's (Roche)$ 2234.30
Tarceva 150 mg x 3 x 10's (Roche)$ 2753.17
Tarceva 25 mg x 30 Tablet (Roche)
Tarceva 100 mg x 30 Tablet (Roche)
Tarceva 150 mg x 30 Tablet (Roche)
Tarceva 100mg TAB / 10 (Roche)
Tarceva 150mg TAB / 10 (Roche)
TARCEVA 150 MG TABLET 1 strip / 10 tablets each (Roche)$ 639.68
Tarceva FC tab 100 mg 30's (Roche)
Tarceva FC tab 150 mg 30's (Roche)
Tarceva FC tab 100 mg 3 x 10's (Roche)
Tarceva FC tab 150 mg 3 x 10's (Roche)
TARCEVA tab 100 mg x 10's (Roche)$ 615.58

References

  1. PubChem. "Erlotinib". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "Erlotinib". http://www.drugbank.ca/drugs/DB00530 (accessed September 17, 2018).
  3. MeSH. "Protein Kinase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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